PMx for Stats

If you are a Statistician trying to learn Clinical Pharmacology these are topics of interest.

Pharmacokinetic (PK) Compartmental Models

• What are Compartmental Models? by Nathan Teuscher

• Biopharmaceutics and Pharmacokinetic Introduction by David W. A. Bourne

How to Run NONMEM

• NONMEM Tutorial Part I: Description of Commands and Options, With Simple Examples of Population Analysis by Robert J. Bauer

• NONMEM Tutorial Part II: Estimation Methods and Advanced Examples by Robert J. Bauer

Basic PK Concepts (CL, half-life, Volume)

• Tutorial for beginners: the concept of clearance explained using the example of a vacuum cleaner by Dong-Seok Yim

• Pharmacokinetics 101 by Shinya Ito

• Basic pharmacokinetics by Soraya Dhillon and Kiren Gill

Physiologically Based Pharmacokinetics (PBPK)

• Applied Concepts in PBPK Modeling: How to Build a PBPK/PD Model by L Kuepfer et al.

• Pharmacodynamic Models and Physiologically Based Pharmacokinetic Models by David W. A. Bourne

Quantitative Systems Pharmacology (QSP)

• Current practices for QSP model assessment: an IQ consortium survey. J Pharmacokinet Pharmacodyn by Chan JR et al.

• FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective by Bai JPF et al.

Population Models - Introduction

• Nonlinear Mixed-Effects Model Development and Simulation Using nlmixr and Related R Open-Source Packages by Matthew Fidler et al.

c-QTc Modeling

• Concentration‐QTc Assessment in Early Phase Trials by Fang Liu et al. 

• Scientific white paper on concentration-QTc modeling by Garnett C et al. 

• Enabling robust assessment of QTc prolongation in early phase clinical trials by Mehrotra DV et al. 

• Model-based evaluation of drug-induced QTc prolongation for compounds in early development by Dubois VF et. al. 

• Impact of Phase 1 study design on estimation of QT interval prolongation risk using exposure–response analysis by Nikolaos T et. al. 

PK/PD Models

• Application of Pharmacokinetic-Pharmacodynamic Modeling in Drug Delivery: Development and Challenges by Huixi Zou et al.

• Modeling of Pharmacokinetics and Pharmacodynamics - Basics by Derendorf and Meibohm

Disease Progression Models

• Disease Progression Modeling: Key Concepts and Recent Developments by SF Cook and RR Bies

• Best practices development and application in disease progression models by the Food and Drug Administration