Tyler Dunlap, Pharm.D., DABCP, Brian Corrigan, Ph.D., Akintunde Bello, Ph.D., Marc Gastonguay, Ph.D.

Presented at the 2026 American Conference on Pharmacometrics (ACoP 2026), an International Conference on Pharmacometrics in the US (ICoP – US), on October 11, 2026.

Biopharmaceutical research and development (R&D) productivity, defined as the aggregate return on investment (ROI) for all drug development activities, is declining despite increased global participation and rapid technological advancement. The use of all available data sources, quantitative modeling to inform all decisions, removal of organizational silos, and adoption of quantitative decision frameworks (QDFs) have been proposed as key strategies to improve R&D productivity. This work aimed to propose a framework for linking pharmacometric, commercial, and financial valuation models to support optimization of a hypothetical Phase 3 trial design with respect to the expected ROI (eROI), defined as the ratio of the risk-adjusted net present value (rNPV) to the committed capital (CC).

Tyler Dunlap, Pharm.D., DABCP, Brian Corrigan, Ph.D., Marc Gastonguay, Ph.D

Presented at the 2026 Annual Meeting of the American College of Clinical Pharmacology (ACCP 2026), on September 27, 2026. Winner of the 2026 ACCP Early-Stage Professional Abstract award. 

Biopharmaceutical research and development (R&D) productivity, defined as the aggregate return on investment for all drug development activities, is declining despite rapid technological advancement. While a multifactorial challenge, this trend is exacerbated by increasingly complex therapeutic modalities and rudimentary decision-making frameworks. While Model-Informed Drug Development (MIDD) has become an established scientific framework among clinical pharmacologists, its contribution to strategic risk management remains underleveraged. This work builds upon previous efforts to integrate pharmacometric, commercial, and financial valuation models into a quantitative decision framework to improve R&D productivity. Here, we propose a framework for identifying the mechanistic drivers of risk for clinical trial failure for a hypothetical Phase 3 study.

Tyler Dunlap, Pharm.D., DABCP¹, Hillary Husband, Ph.D.², Sara Miller, Pharm.D.¹, Alyssa Tilhou, MD, Ph.D.³
¹Metrum Research Group, Boston, MA, USA, ²Louisiana Tech University, Ruston, LA, USA, ³Boston University, Boston, MA, USA

Presented at the 2026 Annual Meeting of the American College of Clinical Pharmacology (ACCP 2026), on September 28, 2026.

Opioid use disorder (OUD) is a chronic relapsing condition characterized by compulsive use of opioids, such as fentanyl, despite significant harms. While buprenorphine, a Mu-opioid receptor (MOR) partial agonist, can effectively stabilize individuals with OUD, withdrawal during induction [due to underdosing or displacement of full agonist opioids (“precipitated withdrawal”)] often leads to treatment discontinuation. Alternative buprenorphine induction strategies have been proposed, but quantitative evidence informing their design is limited. This study introduces a quantitative medicine framework (QMF) to optimize two strategies: macrodosing, characterized by high-dose initiation of buprenorphine with abrupt cessation of nonprescribed opioids to achieve rapid therapeutic receptor occupancy (RO) and avoid underdosing; and microdosing, characterized by low-dose initiation and gradual titration of buprenorphine with continuation of nonprescribed opioids to mitigate risk for precipitated withdrawal.

Yuchen Wang¹, Matthew Wiens², Ke Szeto¹, Timothy Waterhouse², Vivek Purohit¹, Leandro L. Santos³, Jessica Wojciechowski¹
¹Clinical and Quantitative Pharmacology, Incyte Corporation, Wilmington, DE, USA; ²Metrum Research Group, Boston, MA, USA; ³Clinical Development, Incyte Corporation, Wilmington, DE, USA

Presented at the 2026 American Conference on Pharmacometrics (ACoP 2026), an International Conference on Pharmacometrics in the US (ICoP – US), on October 14, 2026.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent nodules, abscesses, and draining tunnels (dTs) that contribute substantially to disease burden. The presence of dTs is indicative of irreversible tissue damage, and a surrogate marker of a more challenging to treat HS, making dT count (dTC) a clinically meaningful endpoint. Povorcitinib is an oral, highly selective Janus kinase 1 inhibitor with demonstrated efficacy in reducing dTC in the phase 3 STOP-HS1 and –HS2 studies. Because dTC changes dynamically over time, a continuous-time Markov model (birth-death process) was developed to characterize the longitudinal relationship between povorcitinib exposure and dTC in patients with moderate to severe HS.

Marc R. Gastonguay, William Knebel, Timothy Waterhouse, Jeannine Fisher, Brian Corrigan

Presented at the 2026 American Conference on Pharmacometrics (ACoP 2026), an International Conference on Pharmacometrics in the US (ICoP – US), on October 12, 2026.

Regulatory submissions for new drugs (NDAs/BLAs) increasingly rely on MIDD (model-informed drug development) analyses to support dosing, labeling, and design of post-approval trial commitments. Frequently, MIDD related activities (data cleaning/prep, analysis, summary document preparation) are on the filing critical path (CP) following completion of the final registration studies, with delays directly impacting time to file. These delays impact overall medicine value and access for patients. This case study highlights a MIDD acceleration (MIDD-A) strategy that resulted in a meaningful reduction in the NDA submission critical path (CP) for an ongoing Phase 3 drug development program.

Brian W. Corrigan, Eric Anderson, Andrew Tredennick, Luis Martinez Lomeli, Megan Cala Pane, Tyler Dunlap, Brian Davis, James Rogers, Marc R. Gastonguay
First published 05 September 2026 in Clinical and Translational Science, Volume 19, Issue 9

Despite integration of artificial intelligence (AI) into drug discovery and an expanding global medicines pipeline, new drug approvals have declined, highlighting a paradox in biopharma: More drugs discovered, but less approvals, higher costs, and longer timelines. Reasons for the decreased research and development (R&D) efficiency are multifactorial, in part driven by the complexity of new modalities, difficult targets and indications, and persistence of cognitive biases in clinical decision-making. One proposed solution to address R&D productivity challenges includes the adoption of organization-wide quantitative decision frameworks (QDFs). QDFs have the potential to increase R&D productivity by integrating quantitative assessments of program risk and value, clinical development costs, time, and probability of success into product valuations.

Andrew Tredennick¹, Matthew Weins¹, Timothy Knab¹, Cole Zmurchok¹, Ahmed Elmokadem²
¹ Metrum Research Group, Boston, MA, USA; ² GlaxoSmithKline (GSK), Collegeville, PA, USA

Presented at the 2026 American Conference on Pharmacometrics (ACoP 2026), an International Conference on Pharmacometrics in the US (ICoP – US), on October 14th, 2026.

Virtual populations (VPops) are widely used in quantitative systems pharmacology (QSP) to represent variability in clinical populations and support model calibration and simulation of treatment outcomes. Practical guidance on selecting among algorithms to generate VPops, and understanding their relative performance, remains limited. The objective of this work was to compare commonly used and emerging VPop generation approaches based on data-simulation matching and computation time.

Population pharmacokinetics of nerandomilast in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis

Megan Pane1, Curtis Johnston1∗, Rena Eudy-Byrne1, Tyler Dunlap1, Nikolas Onufrak2∗, Sonja Hartmann2∗, Steve Choy21Metrum Research Group, Boston, MA, U.S.A.,2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, U.S.A.

∗Affiliation during time of analysis

Mechanism of Action
• Nerandomilast (JASCAYD®) is an orally administered, preferential inhibitor of the
phosphodiesterase-4B (PDE4B) isoenzyme
• PDE4B hydrolyzes and inactivates cyclic adenosine monophosphate
Therapeutic Indication
• Approved by the U.S. FDA and China’s CDE for the treatment of idiopathic pul-
monary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)
• IPF is a specific type of interstitial lung disease (ILD) and PPF is associated with a
subset of ILDs distinct from IPF
• Both IPF and PPF lead to lung scarring that progresses over time, with a median
survival time of 3-5 years
Chemical and Metabolic Properties
• Nerandomilast (R-enantiomer) contains a chiral sulfoxide group and undergoes a
minor level of metabolic chiral inversion following oral administration
• The resulting S-enantiomer is pharmacologically inactive
• Both nerandomilast and the S-enantiomer were characterized in this analysis

Presented at the ASCPT 2026 Annual Meeting. An exposure-response model was developed to evaluate the effect of nerandomilast on forced vital capacity (FVC) in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) , capturing both an initial “offset effect” and a long-term “disease-modifying effect” on the rate of FVC decline. The analysis confirmed a positive exposure-response relationship that is maintained regardless of the underlying diagnosis. Furthermore, simulations support using an 18 mg twice-daily dose to mitigate the reduced drug exposure associated with background pirfenidone use, ensuring a robust treatment response for patients on multi-drug regimens.

Simulated efficacy of nerandomilast on forced vital capacity decline in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis across background antifibrotic therapies Samuel P. Callisto1, Kyle Baron1, Elias Clark1, Curtis Johnston1∗, Nikolas Onufrak2∗, Sonja Hartmann2∗, Steve Choy2 1Metrum Research Group, Boston, MA, U.S.A., 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, U.S.A. ∗Affiliation during time of analysis Introduction.   

ACCELERATION OF CRITICAL PATH MODEL INFORMED DRUG DEVELOPMENT (MIDD) SUBMISSION ACTIVITIES VIA DATA AND TOOL STANDARDIZATION Brian W. Corrigan¹, Matthew Riggs¹, Mike Ferguson¹, Joydeep Bhattacharya¹, Marc R. Gastonguay¹ 1 Metrum Research Group, Boston, MA, USA

Regulatory submissions for new drugs (NDAs/BLAs) increasingly rely on
pharmacometric (PK/PD) analyses to support dosing, labeling, and design of
post-approval trial commitments.
More frequently, MIDD related activities (data cleaning/prep, analysis,
summary document preparation) are on the filing critical path (CP) following
completion of the final registration studies, with delays directly impacting
time to file. These delays impact overall medicine value.
Accelerating MIDD related CP activities via methods standardization,
process automation, and proactive planning offers a potential mechanism for
increasing speed without compromising quality

A MODEL INFORMED DRUG DEVELOPMENT (MIDD)-BASED QUANTITATIVE DECISION FRAMEWORK (QDF) FOR IMPROVING R&D PRODUCTIVITY: PROOF OF CONCEPT FOR ATOPIC DERMATITIS (AD)

E. Anderson¹, BW. Corrigan¹, M. Cala Pane¹, A. Tredennick¹, T. Dunlap¹, L. Lomeli¹, B. Davis¹, MR.Gastonguay¹1Metrum Research Group, Boston, MA

Project Rationale

QDF Components QDF Components
Competitive Landscape
MIDD Enhanced Valuations

Rising costs, uncertain reimbursement, competition, and declining success rates have
reduced drug R&D productivity and investment over the last decade.
Proposed strategies to improve R&D productivity include four key factors: 1) leveraging all
data sources; 2) utilizing quantitative models; 3) elimination of information silos across R&D
and commercial organizations; and 4) application of decision frameworks to reduce
cognitive bias and improve decision making.1

A QDF for a drug development program in atopic dermatitis (AD) was developed to: 1) link
MIDD models aligned with a target product profile (TPP) to risk-adjusted net present value
(rNPV); and 2) integrate context-sensitive large language models (LLMs) to incorporate
non-structured data from novel sources into the decision-making framework in a responsible
manner.

Presented at ACCP Annual Meeting 2025. This work showcases the OptiDose method in mrgsolve, enabling efficient and systematic optimization of dosing regimens with respect to both efficacy and safety considerations. By optimizing across multiple clinical endpoints and patient preferences, these model-informed strategies can guide patient-centered dosing decisions in oncology.

Presented at the PGRN 2025 Scientific Meeting, held in collaboration with ClinPGx, September 10–12, 2025 at the University of Montana in Missoula, where together leaders in pharmacogenomics and clinical pharmacology came together to advance the science and practice of precision medicine.

Pharmacogenetics (PGx) provides critical insights into how genetic variability influences drug metabolism, disposition, and response. This presentation highlights how when incorporated into population PK models, PGx information can:

• Identify subgroups with distinct pharmacokinetic profiles
• Improve predictions of individual dose–response relationships
• Support precision dosing strategies that optimize efficacy while minimizing toxicity

Integrating PGx into quantitative modeling is a powerful step toward making personalized medicine a clinical reality.

This paper contributes to the oncology MIDD field by using robust exposure-response modeling to identify the optimal dosing regimen for HER3-DXd in EGFR-mutated NSCLC. Analyzing data from over 700 patients across four studies, it demonstrates that 5.6 mg/kg Q3W offers a favorable balance of efficacy and safety. The analysis incorporates patient covariates and compares fixed and up-titration regimens, supporting data-driven selection. These methods align closely with the goals of Project Optimus, emphasizing the importance of modeling and simulation in selecting doses that are both effective and tolerable, rather than defaulting to the maximum tolerated dose.

Presented at the Indiana CTSI Pharmacometrics Modeling and Simulation Symposium 2025. Dr. Tim Waterhouse explores the complexities of modeling an antibody-drug conjugate (ADC) for targeted cancer treatment, covering pharmacokinetics models with multiple clearance pathways and exposure-response models in a Bayesian framework.

Presented at ACoP 2024. Efavirenz is metabolized primarily by CYP2B6, to form 8-OH EFV, and also by CYP2A6, to form 7-OH EFV. Upon chronic administration, efavirenz induces both CYP2B6 and CYP2A6, leading to autoinduction of its metabolism. A population pharmacokinetic model was constructed to quantify the impact of CYP2B6 phenotype on efavirenz autoinduction and subsequent exposure.

Presented at ACoP 2024. The poster introduces a framework for developing physiologically based pharmacokinetic (PBPK) models that incorporate partial differential equations (PDEs) to account for spatial drug distribution, using open-source Julia tools. This approach simplifies the integration of spatial components into PBPK models, demonstrated through a case study on naphthalene diffusion, and is applicable to various pharmacometric models requiring spatial considerations, such as topical, inhaled, and antitumor therapies.

Presented at ACoP 2024. This poster describes additions to mrgsolve to facilitate adaptive dosing simulations. A case study is also presented where these tools were utilized to evaluate dose adjustment guidance for valemetostat in patients with non-Hodgkin lymphoma.

Presented at ACoP 2024. This poster describes the scientific project management role in MIDD and it’s benefits over a traditional project management approach.

Presented at ACoP 2024. A proof-of-concept was conducted using deep reinforcement learning to optimize vancomycin dosing based on predicted PK profiles. The reinforcement learner was able to produce dose recommendations that (on average) exceeded the standard-of-care recommended dose, and future opportunities for using reinforcement learning within pharmacometrics are vast with a large potential for impact through personalized dosing.

Presented at ACoP 2024. SHAP analyis, an interpretable ML technique, was applied to PopPK models with two examples: saturable PK and causal dependence in covariates. This analysis yieled insights beyond forest plots and clairified differences in different types of forest plots typically presented.

Presented at ACoP 2024. A longitudinal joint model of modified mayo scores and dropout for patients with ulcerative colitis receiving etrasimod was developed in two Phase 3 studies. This poster presents the development of the model in a Bayesian framework, illustrating the ability of the model to adequately describe changes in efficacy scores in the presence of a spike in dropout at the end of a maintenance phase.

Presented at ACoP 2024. The poster presents a framework for pharmacometric and quantitative systems pharmacology (QSP) model composition using open-source Julia tools. This framework allows for seamless integration and reuse of independent model components, facilitating the creation of complex models from simpler ones, and demonstrating applications in drug interactions, viral dynamics, and bispecific antibody modeling.

Presented at ACoP 2024. A Gompertz distribution is implemented in Stan and brms to enable cure rate survival modeling. The Gompertz brms family can be used to model exposure-response data in a Bayesian framework where a proportion of the population never experiences the event of interest.

Presented at ACoP 2024. In this analysis aimed to evaluate the ability to estimate robust population PD parameters and a landmark endpoint in different scenarios. In the primary workflow different levels of missing PK data were tested. Additionally, varying degrees of of individual-level and residual variability were tested. Finally, scenarios with smaller populations were tested. In all scenarios, PD parameters and endpoints could be estimated with adequate accuracy and precision.

Presented at ACoP 2024. A Bayesian model of the probability of dose modification as a function of platelet and neutrophil counts was developed to characterize the dynamic and probabilistic nature of dose decisions. The dose modification model was successfully integrated into a dynamic simulation framework accounting for the impact of safety on dose.

This study characterizes the population pharmacokinetics (PK) of vedolizumab in adults undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) for graft-versus-host disease (GvHD) prophylaxis. The analysis identified body weight and albumin levels as significant predictors of vedolizumab clearance, though the covariates studied had no clinically meaningful effect on its overall PK. The findings offer important insights into dosing strategies for vedolizumab in this patient population.

The paper details a collaborative initiative funded by the FDA, where the Critical Path Institute and partners created didactic e-learning materials on model-informed drug development (MIDD) for non-modeling audiences. The curriculum, enriched with case studies from multinational pharmaceutical companies, includes 13 hours of training videos and is currently being beta-tested by FDA reviewers. Future plans involve expanding the content, offering 1:1 mentorship sessions, and providing broader access to the learning management system to support global stakeholders and the evolving MIDD community.

Presented at PAGE 2024 – Hands-on Workshop. MeRGE is a suite of freely-available, open-source tools for scalable, reproducible pharmacometric workflows. MeRGE consists of individual but interconnected R packages that support scalability and reproducibility during: project setup, data assembly, data exploration, model development, execution, and evaluation, simulation, and reporting.

Presented at PAGE 2024. This model, developed by Boehringer Ingelheim in collaboration with Metrum Research Group, provides insights into potential anemia risks and informs monitoring strategies for patients with cognitive impairment associated with schizophrenia.

Presented at the 37th New England Statistics Symposium (NESS).Dr. Jim Rogers from MetrumRG as he illustrates the use of causal inference frameworks for evaluating pediatric extrapolation plans.

Covariate analysis is typically performed, and results are reported, based on the purpose of the analysis and the anticipated audience. Failure to use a standard for reporting parameters has made it difficult to find common features of models and use covariate analysis in a consistent way in order to discover new knowledge. This article aims to provide a useful basis for analysts to choose the most appropriate approach for their specific sets of circumstances.

Presented by Dr. Sam Callisto and Michael Heathman at the CTSI Disease and Therapeutic Response Modeling Symposium, February 2024.
View presentation recording.

Presented at ASCPT Annual Meeting 2024. A population PK and turnover models were developed and show that the extent of efavirenz autoinduction and clearance is dependent on CYP2B6 genotype.

Presented at ASCPT Annual Meeting 2024. Discover the synergy between Machine Learning and classical approaches in covariate identification. Our scientist, Matthew Wiens, explored this vital topic at the pre-conference session ‘Empowering Clinical Pharmacologists and Translational Scientists Using Artificial Intelligence: Unlocking Potential with Cutting-Edge Use Cases.’

Presented at the International Symposium on Biopharmaceutical Statistics, March 2024. From basic dose adjustments to more ambitious programs for personalized medicine, pharmacometrics has a long tradition of informing tailored treatment strategies. Many of the modeling strategies are well-precedented, but formal decision frameworks are needed to address the question: how much data is enough to support a decision?

This research delves into the significance of transitioning from intravenous (i.v.) to subcutaneous (s.c.) administration of biologics in enhancing patient convenience and treatment outcomes. It emphasizes the role of model-informed drug development (MIDD) in facilitating this transition, providing insights into crucial clinical pharmacology and regulatory considerations. Key aspects highlighted include comprehensive pharmacokinetic evaluations, exposure-response profiling, comparability studies, and safety assessments, with MIDD strategies aiding in expediting the shift to s.c. dosing, thereby improving patient adherence and clinical efficacy.

GPKPDviz is a Shiny application designed for real-time simulation, visualization, and assessment of PK/PD models. The app allows the generation of virtual populations, simulation of diverse dosing scenarios, and assessment of covariate and dosing regimen impacts on PK/PD endpoints. It supports loading actual population data from clinical trials and offers a streamlined workflow for efficient modeling.

Introduction to exposure-response (E-R) concepts. Presented at the 79th Annual Deming Conference on Applied Statistics.

In this tutorial, the principles of Bayesian model development, assessment and prior selection are outlined. An example pharmacokinetic model is used to demonstrate the implementation of Bayesian modeling using the nonlinear mixed-effects modeling software NONMEM.

Many biostatisticians in pharma and biotech  have relatively little awareness of, let alone influence over, the heavily statistical “pharmacometric” reasoning that goes into CTD Section 2.7.2 of an FDA regulatory submission, the “Summary of Clinical Pharmacology Studies”.  This talk focuses on the value of increasing statistical influence in pharmacometrics and the path to get there.

Presented at ACoP14. This project is dedicated to integrating parameter uncertainty into pharmacometric simulations, which plays a crucial role in making informed decisions in drug development. Initially, the metrumrg package in R was instrumental for simulating both fixed and random effect parameters. However, this package has since been deprecated. Consequently, the primary objective was to create a new R package named simpar. This new package aimed to retain the essential functionalities of metrumrg while expanding its capabilities. The overarching goal was to significantly enhance the support for incorporating parameter uncertainty into pharmacometric simulations, thereby aiding more comprehensive and accurate decision-making processes in this field.

Roller Coaster Talk presented at ACoP14. A workflow was introduced that integrates QSP modeling and machine learning in the form of UDEs. The workflow utilizes machine learning to learn missing parts in our knowledge of a QSP system while quantifying the uncertainty around the learned dynamics using Bayesian analysis.

Presented at ACoP14. Deep compartment models (DCMs) are a proposed alternative to traditional nonlinear mixed effect (NLME) pharmacometrics approaches [1]. DCM uses neural networks to represent estimated pharmacokinetic parameters which can then be used in either closed-form or ordinary differential equation (ODE)-based representations of pharmacokinetic models

Ana Ruiz-Garcia, Paul Baverel, Dean Bottino, Michael Dolton, Yan Feng, Ignacio González-García, Jaeyeon Kim, Seth Robey, Indrajeet Singh, David Turner, Shu-Pei Wu, Donghua Yin, Di Zhou, Hao Zhu, Peter Bonate. J Pharmacokinet Pharmacodyn. March, 4 2023

Tim Waterhouse. Presented at 12th Annual Indiana Clinical and Translational Sciences Institute (CTSI) Symposium on Disease and Therapeutic Response Modeling. February 23, 2023.

Sam Callisto, Tim Waterhouse. Presented at 12th Annual Indiana Clinical and Translational Sciences Institute (CTSI) Symposium on Disease and Therapeutic Response Modeling. February 23, 2023.

Ana-Marija Grisic, Karthik Venkatakrishnan, Jonathan French, Akash Khandelwal. CPT Pharmacometrics Syst Pharmacol.  December, 20 2022. doi:10.1002/psp4.12905

Rena Eudy-Byrne, Matthew Riggs, Amale Hawi, Thomas Sciascia, Shashank Rohatagi. Br J Clin Pharmacol. 2023.  doi:10.1111/bcp.15663

Ahmed Elmokadem, Yi Zhang, Timothy Knab, William R. Gillespie. CPT Pharmacometrics Syst Pharmacol.  January, 20 2023. doi:10.1002/psp4.12926

Sonoko Kawakatsu. Virtual presentation for Children’s Hospital of Philadelphia and Cincinnati’s Children’s Hospital. 13 December 2022.

Simon Dagenais, Marc Gastonguay, Abie Ekangaki. Hot topic presented at 2022 AAPS PharmSci360. 17 October 2022.

James Rogers, Hugo Maas, Alejandro Perez Pitarch. CPT Pharmacometrics Syst Pharmacol.  November, 16 2022. doi:10.1002/psp4.12894

Kosalaram Goteti, Jonathan French, Ramon Garcia, Ying Li, Florence Casset-Semanaz, Aida Aydemir, Robert Townsend, Cristina Vazquez Mateo, Matthew Studham, Oliver Guenther, Amy Kao, Marc Gastonguay, Pascal Girard, Lisa Benincosa, Karthik Venkatakrishnan. CPT Pharmacometrics Syst Pharmacol.  November, 9 2022. doi:10.1002/psp4.12888

Kosalaram Goteti, Ramon Garcia, William Gillespie, Jonathan French, Lena Klopp-Schulze, Ying Li, Cristina Vazquez Mateo, Sanjeev Roy, Oliver Guenther, Lisa Benincosa, Karthik Venkatakrishnan. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster T-075

Kyle Baron, Sam Callisto, Seth Green, Matthew Riggs. A showcase of open-source tools for scalable, reproducible PMx workflows. Pre Meeting Workshop presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October 2022.

Ahmed Elmokadem, Yi Zhang, Tim Knab, Eric Jordie, William R. Gillespie. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster W-074

James A. Rogers, Hugo Maas, Alejandro Peréz. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster T-022

Katherine Kay, Kyle Baron, Seth Green, Samuel Callisto, Curtis Johnston, Kyle Barrett, Devin Pastoor, Jim Rogers, Ana Ruiz-Garcia, Tim Waterhouse, Matthew Wiens, Matthew Riggs. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster M-062

Jonathan French. Presented at Bayes 2022. 12 – 14 October 2022.

Seth Green. Presented at R/Medicine 2022. 26 August 2022.

Jeffrey S. Barrett, Megan Cala Pane, Timothy Knab, William Roddy, Jack Beusmans, Eric Jordie, Kanwaljit Singh, Jonathan Michael Davis, Klaus Romero, Michael Padula, Bernard Thebaud, Mark Turner. Front. Pharmacol. 2022 October 12. doi: 10.3389/fphar.2022.988974

Matthew Riggs. Presented at the University of Buffalo QSP Symposium 2022. 28 July 2022

QSP to Link Learn:Confirm with Expand:Understand in Model-Informed Drug Development

Charles C. Margossian, Yi Zhang, William R. Gillespie. Flexible and efficient Bayesian pharmacometrics modeling using Stan and Torsten, Part I. CPT Pharmacometrics Syst Pharmacol. 2022 May 15. doi: 10.1002/psp4.12812. Epub ahead of print. PMID: 35570331.

Seth C. Hopkins, Sean D. Wilson, Ajay Ogirala, Gabriel Stellman, Snezana M. Milanovic, Steven T. Szabo, James A. Rogers, Chris J. Edgar, Kenneth S. Koblan. Poster presented at 2021 American College of Neuropsychopharmacology. 5-8 December 2021.

William R. Gillespie. The Lewis B. Sheiner Lecturer Award slides presented at International Society of Pharmacometrics. November 2021.

Yi Zhang and William R. Gillespie. Poster presented at 2021 American Conference on Pharmacometrics (ACoP12) virtual meeting. 8-12 November 2021. Poster PIIIB-028

Kyle T. Baron, Devin Pastoor, Anna Nevison, Katherine Kay, Marc R. Gastonguay. Poster presented at Population Approach Group Europe Annual Meeting; 2-3 and 6-7 September 2021.  Poster III-02.

Yi Zhang and William R. Gillespie.  Poster presented at Population Approach Group Europe Annual Meeting; 2-3 and 6-7 September 2021.  Poster I-61.

Seminar presented by Marc R. Gastonguay, Ph.D., at the FDA’s Model Informed Drug Development (MIDD) Education Series, April 26, 2021 (virtual).

Marc Gastonguay, Jing Liu, Jean Lachaine, Anna G. Kondic, and Daniel Polhamus.  Presented at the American Society for Clinical Pharmacology (ASCPT) annual meeting, March 15, 2021.

Presentation by Marc Gastonguay for the ASCPT Sheiner-Beal Award during the American Society for Clinical Pharmacology (ASCPT) annual meeting, March 11, 2021.

Uechi L, Jalali M, Wilbur JD, French JL, Jumbe NL, Meaney MJ, Gluckman PD, Karnani N, Sakhanenko NA, Galas DJ; GUSTO study group. PLoS One. 2020 Dec 3;15(12):e0242684. doi: 10.1371/journal.pone.0242684.

Yi Zhang, William R. Gillespie, Ben Bales, Aki Vehtari.  Poster presented at 2020 American Conference on Pharmacometrics (ACoP11) virtual meeting. 11 November 2020.

Presentation by Jonathan L. French, Sc.D. at 2020 American Conference on Pharmacometrics (ACoP11) virtual meeting. 11 November 2020.

Presentation by Marc Gastonguay, Ph.D. at 2020 American Conference on Pharmacometrics (ACoP11) virtual meeting. 11 November 2020.

Utsey, Kiersten, Madeleine S. Gastonguay, Sean Russell, Reed Freling, Matthew M. Riggs, and Ahmed Elmokadem. 2020. Drug Metabolism and Disposition: The Biological Fate of Chemicals, July. https://doi.org/10.1124/dmd.120.090498.

Presented by Jonathan French, Sc.D., at the American Conference on Pharmacometrics (ACoP10) during the tutorial: The Role of Pharmacometrics in Advancing Quantitative Benefit-Risk Assessments for Drug Review and Approval. 24 Oct 2019

Presented by Ahmed Elmokadem, Ph.D at the 9th Annual CTSI Disease and Therapeutic Response Modeling and Simulation Symposium at Indiana University School of Medicine on November 12, 2019. Event details can be found here.

Presented by Marc Gastonguay, Ph.D. at ACCP Annual Meeting September 17, 2019.

Pastoor, Devin. Presentation at R/Pharma. Cambridge, MA. 22 Aug 2019.

Gastonguay, Madeleine. Presentation at R/Pharma. Cambridge, MA. 23 Aug 2019.

Gastonguay MS, Russell S, Freling R, Riggs M, Kay K, Utsey K, Elmokadem A.

Poster presented at 2019 American Society for Clinical Pharmacology & Therapeutics (ASCPT). Washington DC. 14 March 2019.

Poster presented at ISoP Regional QSP Day 2019. Princeton, NJ. 16 July 2019.

Zhang Y,  Gillespie W. Poster presented at 2019 Population Approach Group in Europe (PAGE). Stockholm, Sweden. 13 June 2019. Abstract IV-29.

Rogers JA. CPT Pharmacometrics Syst Pharmacol [Internet]. 2019 Feb 14; Available from: http://dx.doi.org/10.1002/psp4.12395

Rogers JA. Presentation at 2018 American Conference on Pharmacometrics (ACoP9). San Diego, CA. 9 Oct 2018.

Elmokadem A. Poster presented at 2018 American Conference on Pharmacometrics (ACoP9). San Diego, CA. 9 Oct 2018. Abstract #M-003.

Elmokadem A. Lightning talk presented at International Society of Pharmacometrics New England 2018. Cambridge, MA. 12 Sep 2018.

Gastonguay MS. Presented at the R/Medicine 2018 Conference. New Haven, CT. 8 Sep 2018.

Zhang Y, Gillespie WR, Minjie Zhu. Poster presented at StanCon. Helsinki, Finland. 30 Aug 2018.

Trame MN, Riggs MM, Biliouris K, Marathe D, Mettetal J, Post TM, Rizk ML, Visser SAG, Musante CJ.  CPT Pharmacometrics Syst Pharmacol. doi:10.1002/psp4.12313. 21 August 2018.

Gastonguay MR. Lightning Talk presented at the 1st annual R/Pharma conference. Boston, MA. 16 August 2018.

Kang J. Lightning Talk presented at the 1st annual R/Pharma conference. Boston, MA. 16 August 2018.

Pastoor D. Invited Talk presented at the 1st annual R/Pharma conference. Boston, MA. 15 August 2018.

Gillespie WR. Presented at Stan for Pharmacometrics. Paris, France. 24 July 2018.

Moore JN, Gastonguay MR, Ng CM, Adeniyi-Jones SC, Moody DE, Fang WB, Ehrlich ME, Kraft WK. Clin Pharmacol Ther. 103 (6) 1029-1037; June 2018

Vujkovic M, Bellamy SL, Zuppa AF, Gastonguay MR, Moorthy GS, Ratshaa B, Han X, Steenhoff AP, Mosepele M, Strom BL, Bisson GP, Aplenc R, Gross R. Pharmacogenomics J. doi: 10.1038/s41397-018-0028-2. Epub June 1, 2018.

Park SY, Xiao L, Wilbur JD, Staicu A, Jumbe NL. Computational Statistics and Data Analysis. 122:101-114. June 2018

Gillespie WR. Presented at the Midwest Biopharmaceutical Statistics Workshop (MBSW), Indianapolis, IN, May 2018.

Ocampo-Pelland AS, French JL.  Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Gastonguay MR. Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Margossian C and Gillespie WR.  Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Gastonguay MR. Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Gastonguay MR.  The International Society of Pharmacometrics Lewis B. Sheiner Award Lecture presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 15, 2017.

Park SY, Xia L, Wilbur J, Staicu AM, Jumbe NL.  Paper presented at: Eastern North American Region (ENAR) Spring Meeting of the International Biometric Society, March 2017, Washington, DC.

Margossian CC and Gillespie WR.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Gillespie WR. Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Gillespie WR.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Hajjar J, French JL, Gastonguay MR.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Melhem M, Polhamus D, Lau T, Chen P, Narayanan A, Clements JD, Gibbs J, Seegan G.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Gillespie WR and Margossian CC.  Presented at Stan for Pharmacometrics Day, Paris 22 Sep 2016.

Polhamus D.  Presented at The Joint Statistical Meetings (JSM), August, 2016.

Park SY, Xia L, Wilbur J, and Staicu, AM.  Presented at The Joint Statistical Meetings (JSM), August 2016, Chicago, IL; Abstract 319197.

Polhamus D, French J, Chen SC, Wang B, Li C, Lu D, Girish S, Jin J, Quartino A.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

French JL, Racine A, van Buuren S, Haggstrom J.  Presented at the Annual Meeting for the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Wilbur JD, Ohuma E, Xiao L, Mouksassi S, Hafen R.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Gastonguay MR.  Presented at the Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics: FDA – U Maryland CERSI Cosponsored Workshop.  FDA. June 1, 2016.

Eudy RJ, Riggs MM, Baron K.  Presented at the Sanofi–MSISB Mount Sinai Systems Pharmacology Symposium, June 2016.

Flockhart D, Bies RR, Gastonguay MR, Schwartz SL.  Br J Clin Pharmacol. 2016 May;81(5):804-6.

Ocampo-Pelland AS, Gastonguay MR, French JF, Riggs MM.  J Pharmacokinet Pharmacodyn. 2016 Apr;43(2):191-206.

Conrado DJ, Hather GJ, Chen D, Denney WS. Facilitating Cardiovascular Safety Exposure-Response Modeling in Early-Phase Clinical Studies with the cardioModel Package for R.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA, October 2015

Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Polhamus D, French J, Chen S-C, Wang B, Li C, Lu D, Girish S, Jin J, Quartino A.  Presented at the 6th American Conference on Pharmacometrics, Arlington, VA; October 2015.

Baron KT and Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Eudy RF, Gillespie WR, Riggs MM, Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Hajjar J, Fisher J, Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Bergsma T and Pivirotto S.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA, October 2015.

Gastonguay MR and Godfrey CJ.  American College of Clinical Pharmacology (ACCP) Workshop, September 26, 2015.

Eudy RJ, Riggs MM, Gastonguay MR. AAPS J. 2015 Sep;17(5):1280-4.

Ocampo-Pellend AS, Gastonguay, French JL, Riggs MM. Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Hersonissos, Greece; June 2015.

Peterson MC and Riggs MM.  CPT: Pharmacometrics & Systems Pharmacology, 2015 Mar; 4(3).

Romero K, Sinha V, Allerheiligen S, Danhof M, Pinheiro J, Kruhlak N, Wang Y, Wang SJ, Sauer JM, Marier JF, Corrigan B, Rogers J, Lambers Heerspink HJ, Gumbo T, Vis P, Watkins P, Morrison T, Gillespie W, Gordon MF, Stephenson D, Hanna D, Pfister M, Lalonde R, Colatsky T. Journal of Pharmacokinetics and Pharmacodynamics, 2014 Dec;41(6):545-52. doi: 10.1007/s10928-014-9390-0.

Polhamus DG, Kang J, Rogers JA, and Gastonguay MR. Presented at the 7th Annual Clinical Trials on Alzheimer’s Disease (CTAD), November 2014.

Eudy RJ and Gastonguay MR. Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.

Bergsma T and Pivirotto S.  Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.

Knebel W, Gastonguay M, Polhamus D, Hane JT. Presented at the Annual Meeting of the Population Analysis Group in Europe (PAGE), Alicante, Spain; June 2014; Abstract I-55.

J. S. Gewandter, R. H. Dworkin, D. C. Turk, M. P. McDermott, R. Baron, M. R. Gastonguay, I. Gilron, N. P. Katz, C. Mehta, S. N. Raja, S. Senn, C. Taylor, P. Cowan, P. Desjardins, R. Dimitrova, R. Dionne, J. T. Farrar, D. J. Hewitt, S. Iyengar, G. W. Jay, E. Kalso, R. D. Kerns, R. Leff, M. Leong, K. L. Petersen, B. M. Ravina, C. Rauschkolb, A. S. C. Rice, M. C. Rowbotham, C. Sampaio, S. H. Sindrup, J. W. Stauffer, I. Steigerwald, J. Stewart, J. Tobias, R.-D. Treede, M. Wallace, and R. E. White.  Pain. 2014 Sep;155(9):1683-95. doi: 10.1016/j.pain.2014.05.025. Epub 2014 May 24.

Bergsma T, Knebel W, Polhamus D, Hane JT, Gastonguay MR. Presented at the 4th American Conference on Pharmacometrics (ACoP), Ft. Lauderdale; May 2013.

Bergsma TT, Knebel W, Fisher J, Gillespie WR, Riggs MM, Gibiansky L, Gastonguay MR. Comput Methods Programs Biomed. 2013 Jan;109(1):77-85.

Bergsma TT and Smith MS. The R Journal; June 2012, Vol. 4 Issue 1, p60-63.

Polhamus D, Rogers JA, Gillespie W, French J, and Gastonguay M.  Presented at the 21st Annual Meeting of the Population Approach Group Europe (PAGE), Venice, Italy, June 2012, Abstract 2580.

Hane J and Kraut A.  Presented at BioIT World Conference and Expo, Boston, MA; April 23-25, 2012.

Rogers JA, Polhamus D, Ito K, Qiu R, Gillespie W, Corrigan B. Presented at the 2012 American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, National Harlbor, MD; March 2012.

Davies K.  Bio-IT World, Feb 14, 2012.

Gastonguay MR.  Presented at the 20th Annual Meeting of the Population Approach Group Europe (PAGE),  Athens, Greece,  June 2011. Abstract 2229.

Gibbs JP, Emery MG, McCaffery I, Smith B, Gibbs MA, Akrami A, Rossi J, Paweletz K, Gastonguay MR, Bautista E, Wang M, Perfetti R, Daniels O.  J Clin Pharmacol. 51(6):830-41. June 2011.

Bergsma T. Presented at ACOP; April 2011; San Diego, CA.

Bergsma T, Fisher J, Gastonguay MR, Hane J, Knebel W, Riggs MM, Rogers JA. Presented at ACOP; April 2011; San Diego, CA.

Knebel W, Tammara B, Udata C, Comer G, Gastonguay MR, Meng X.  J Clin Pharmacol. 51(3):333-45. March 2011.

Rogers JA, Ito K, Gillespie WR, Corrigan BW, Gastonguay MR. Presented at the Fourth Annual Bayesian Biostatistics Conference, Houston, TX. 26–28 January 2011.

Rogers JA, Wilbur J, Cole S, Bernhardt PW, Bupp JL, Lennon MJ, Langholz N, Steiner CP. Statistics in Biopharmaceutical Research. 3(4):515-525. (2011)

Riggs MM.  2010 AAPS Clinical Pharmacology and Translational Research (CPTR) Open Forum; 16 November 2010.

Romero K, Corrigan B, Tornoe CW, Gobburu JV, Danhof M, Gillespie WR, Gastonguay MR, Meibohm B, Derendorf H. J Clin Pharmacol. 50(9 Suppl):9S-19S. September 2010.

Pfister M, Brundage RC, Gastonguay MR, Miller R, Tannenbaum SJ, D’Argenio DZ. J Clin Pharmacol. ;50(9 Suppl):158S. September 2010.

Brundage RC, Pfister M, D’Argenio DZ, Gastonguay MR, Miller R, Tannenbaum SJ. J Clin Pharmacol. 50(9 Suppl):7S-8S. September 2010.

Gastonguay MR, Gillespie WR, Bauer RJ. Presented at PAGE 2010. Berlin, Germany. 8–11 June 2010

Knebel W, Bergsma TT, Dagdigian C, Hane J, Gastonguay MR. Presented at PAGE 2010, 19th Meeting, Berlin, Germany, June 8–11, 2010.

Peterson MC and Riggs MM. Presented at American Association of Pharmaceutical Scientists National Biotechnology Conference, Update on Quantitative Systems and Disease Models for Biologics. Mini–Symposium. San Francisco, CA; May 2010.

Su F, Nicolson SC, Gastonguay MR, Barrett JS, Adamson PC, Kang DS, Godinez RI, Zuppa AF. Anesth Analg. 110(5):1383-92. May 2010.

Riggs MM. Presented at American Association of Pharmaceutical Scientists National Biotechnology Conference, Update on Quantitative Systems and Disease Models for Biologics. Mini–Symposium. San Francisco, CA; May 2010.

Rogers JA. Presented at 3rd Annual FDA/MTLI Medical Device and IVD Statistics Workshop. 28 April 2010.

Dirks N, Gastonguay MR, Gillespie WR, Knebel W, Riggs MM, Panetta JC, and Meibohm B. Presented at ASCPT 111th Annual Meeting, March 17-20, 2010.

Sweeney KR, Gastonguay MR, Benincosa L, Cronenberger CL, Glue P, Malhotra BK. Drug Discov Ther. 4(1):44-53. February 2010.

Ravva JP, Gastonguay MR, French JL, Tensfeldt TG, and Faessel HM. Clinical Pharmacology & Therapeutics. 87(3):336-44. January 2010.

Mondick JT, Johnson BM, Haberer LJ, Sale ME, Adamson PC, Coté CJ, Croop JM, Russo MW, Barrett JS, Hoke JF. Eur J Clin Pharmacol. 66(1):77-86. January 2010.

Gastonguay MR. Presented at ACOP 2009. 6 October 2009; Mashantucket, CT.

Gillespie WR, Rogers JA, Ito K, Gastonguay MR. Presented at ACOP 2009. October 4-7, 2009; Mashantucket, CT.

Gillespie B, Gastonguay MR. Presented at ACOP 2009. October 4-7, 2009; Mashantucket, CT.

Riggs MM, Peterson MC, Gastonguay MR. Presented at ACOP 2009. October 4-7, 2009; Mashantucket, CT.

Nicholas T, Knebel W, Gastonguay MR, Bednar MM, Billing B, Landen JW, Kupiec JW, Corrigan B, Laurencot R, Zhao Q. Poster presented at the ICAD 2009 Annual Meeting; July 11–16, 2009; Vienna, Austria.

Gillespie B, Rogers JA, Ito K, Gastonguay MR. ASCPT 110th Annual Meeting, March 18-21, 2009; Washington D.C.

Knebel W, Palmen M, Dowell JA, Gastonguay M. J Clin Pharmacol. 48(7):837-48. July 2008.

Fisher J, Gastonguay MR, Knebel W, Gibiansky L, Wire MB. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Riggs MM, Bergsma TT, Gillespie WR, Gastonguay MR, Sprenger KJ. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Gillespie WR, Gastonguay MR, Knebel W, Georgalis G. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Knebel W, Bergsma T, Fisher J, Georgalis G, Gibiansky L, Gillespie WR, Riggs MM, Gastonguay MR. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Gillespie WR, Gastonguay MR, Knebel W. Presented at the AAPS Annual Meeting; November 2007; San Diego, CA.

Knebel W, Rao N, Bergsma T, Gastonguay M, Mori A, Uchimura T, Allenby K, Dvorchik B, Sussman N, Chaikin P. Presented at ACCP; October 14-17, 2007; Denver, CO.

Rawa P, Faessel H, Gastonguay MR, Tensfeldt TG, Reeves K. Clin Pharmacol Ther. 81(S1) March 2007; Abstract PII-73: S72.

Riggs M. FDA/Industry Statistics Workshop. 29 September 2006; Washington D.C.; Parallel Session 14: Case Studies in Modeling and Simulation, Abstract.

Agoram B, Heatherington AC, Gastonguay MR. AAPS Journal. 8(3), September 2006. doi: 10.1208/aapsj080364

Gastonguay MR, Gibiansky L. Presented at the ECPAG Conference. July 24-26, 2006; Rockville, MD; Workshop Poster Session, Abstract.

Mondick JT, Gibiansky L, Gastonguay MR, Veal GJ, Barrett JS. Presented at PAGE 2006. June 14-16, 2006; Brugge/Bruges, Belgium; Abstract 938.

Gibiansky L and MR Gastonguay. Presented at PAGE 2006. June 14-16, 2006; Brugge/Bruges, Belgium; Abstract 958.

Gastonguay MR, Gibiansky L. Presented at the MUFPADA Annual Meeting. May 2-3, 2006; Ann Arbor, MI; Abstract.

Knebel B, Bergsma T, Gibiansky L, Hane JT, Gastonguay MR. Presented at PAGE Annual Meeting. June 16-17, 2005; Pamplona, Spain; Abstract 779.

Gastonguay MR, El-Tahtawy A. The AAPS Journal. 7(S2), June 2005. Abstract W5318.

Gastonguay MR, El-Tahtawy A. Clinical Pharmacology and Therapeutics. 77(2), P2-P2; February 5, 2005.

Gibiansky E, Gibiansky L, Enriquez J. Clinical Pharmacology and Therapeutics. 77(2), P48-P48; February 5, 2005.

Gibiansky L. Presented at AAPS Annual Meeting: PPDM Poster-Podium Session, November 10, 2004; Baltimore, MD.

Gastonguay MR, Bies R. The AAPS Journal. 6(S1) (2004); Abstract W4353, 2004.