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by Johan Gabrielsson and Dan Weiner - 5th Edition eBook

📙 Book - PK/PD Data Analysis - Concepts and Applications

Training Courses, Certifications,  Video Tutorials, Tips, Learn PK/PD Concepts and more

Training (How to)

Browse our formalized training courses offering

📔 Certara University Class Curriculum

Introduction to PK concepts (does not involve Certara software)

📘 Conceptual Training Courses

Learn to do NCA and individual modeling using Phoenix WinNonlin

📈 PK/PD Training Courses using Phoenix WinNonlin

Learn to create and validate population models in Phoenix

👨‍👩‍👧‍👧 Population PK/PD Training Courses using Phoenix NLME

Earn a certification to demonstrate your skill and knowledge

👩‍🏫 Certara Professional Certifications

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📦 Certification Bundles

🎓 Certara University Masterclasses

Certara University offers professional courses and certifications to learn PK/PD scientific foundations and software expertise

🎓 Certara University PK/PD Training Courses

Access complimentary tutorials and tips on how to use WinNonlin, NLME, IVIVC Toolkit, from charting to running simulations.

📉 Phoenix Resources (WinNonlin, NLME, RsNLME, and IVIVC)

Obtain Phoenix Templates for Bioequivalence

📦Free Phoenix Templates for Bioequivalence Regulatory Guidances

Phoenix Templates

This is a series of webinars that were hosted by Certara to teach people to become more familiar with PML coding of PK and PK/PD models.  It is a series…

PML School Introduction

A 3-compartment model with nonlinear clearance.

Lesson 1: Nonlinear Clearance

Simultaneous fitting of parent and metabolite where the metabolite clearance follows Michaelis-Menten kinetics.

Lesson 2: Metabolite Kinetics

A two compartment model fitted to pharmacokinetic and pharmacodynamic data in a sequential manner using concentration- and response-time data after multiple oral doses.

Lesson 3: Two-Compartment Repeated Dosing

A model with multiple absorption routes was constructed using the Graphical Model Editor.

Lesson 4: Multiple Absorption Routes

A one-compartment model with IV and PO dosing, and collection of both plasma and urine data.

Lesson 5: Simultaneous Fitting of Plasma and Urine Data

A textual model with target-mediated drug disposition

Lesson 6: Target-Mediated Drug Disposition

A 2-compartment model with recirculation via bile and gut.

Lesson 7: Enterohepatic Recirculation

Two models built, one with 1st-order input, and a second with zero-order input.  The model that fit the data better was identified

Lesson 8: One-Compartment 1st and 0-Order Input

A 2-compartment model fitted to data from mouse, rat, dog and human, Creating Dedrick plots in Phoenix.

Lesson 9: Allometric Scaling

A turnover model of an endogenous compound with saturating elimination, and a highly variable multiple dosing scheme. Results compared with a simple linear elimination model.

Lesson 10: Turnover III - Nonlinear Disposition

Link (Effect Compartment) model, Turnover (Indirect) model and receptor binding model are created and compared.

Lesson 11: Analysis and Comparison of Link, Turnover and Receptor Binding Model

Gompertz, Hill, Logistic, Morgan-Mercer-Flodin, Richards, and Weibull models were created and compared

Lesson 12: Sigmoidal Concentration-Response Models

Gompertz, Jumbe, and Simeoni models are constructed and compared.

Lesson 13: Modeling Tumor Growth/Kill

One-compartment PK model (frozen parameters) with turnover model that fits the PD data

Lesson 14: Modeling Enzyme Inhibition by Means of Turnover

Two PK/PD models are compared: an effect compartment model, and a model that uses the PML delay command.  The process of going from a PK model to a PK/PD model is also…

Lesson 15: Effect Compartment III - IV Infusion

A turnover (Indirect) model, a turnover model with a delay, and two different precursor-pool models.

Lesson 16: Warfarin IV Bolus Turnover Model

Turnover model 4 (stimulation of loss) with frozen PK. PK data are simulated using previously-determined parameters, so we can see the hysteresis loop.

Lesson 17: Turnover Model 4 - IV Infusion

One-compartment PK model with turnover PD model (inhibition of the build-up of response). PK is frozen. 

Lesson 18: Turnover Models with Repeated Dosing

A model that has only Effect and Time data (no PK data).  First-order PK is assumed.  The PD model is a turnover model, with linear stimulation of loss.

Lesson 19: Dose-Response-Time Analysis

A PK/PD model.  The PK is described by a 1-compartment IV bolus model with nonlinear elimination.  The PD is delayed by three transit compartments and a feedback loop.

Lesson 20: Transduction Modeling

Series of Free Webinars for how to create PK/PD models using Pharmacometric Modeling Language

PML School

This is an archive of the NONMEM to NLME webinars that were presented during 2018. The goal is to demonstrate how to convert NONMEM models into Phoenix.

Introduction to the Webinar Series

One compartment model, single IV Bolus of 100 units, first order kinetics.
Parametrization: Cl and V. Multiplicative residual error, and 30% between-subject variability in parameters.  Optimized using FOCE ELS.

Webinar 1: PK 1-Compartment IV Bolus Model FOCE

2-comparment plasma and urine PK model with IV-bolus dosing, clearance parameterization, multiplicative residual error, using the QRPEM engine.

Webinar 2: PK 2 compartment multiple dose- IV bolus Plasma and Urine QRPEMIMP

compartment model with Oral Single Dose, Covariate relationship
between both V and Cl and categorical covariate disease state

Webinar 3: PK 2 compartment oral with Disease State covariate on V and CL

One compartment model, IV Bolus, 3 Dose cohorts (1,10 and 100 ), non linear kinetics, FOCE-ELS engine.

Webinar 4: PK Nonlinear Elimination and Model Validation I Bootstrap

Two compartment model, first-order and zero order saturable absorption, Doses ranging from 1-800

Webinar 5: Mixed Absorption and Model Validation II VPC

Webinar 6: Running NONMEM and Phoenix NLME in the Cloud

Emax model with baseline and shape factor, multiplicative residual error, random effects, using the FOCE-ELS engine

Webinar 7: PD Emax inhibitory with baseline and shape factor

PD Indirect response model using frozen PK parameters.

Webinar 8: PD Indirect Response with IV Bolus Dosing

One compartment model, single IV infusion of 100 units.  Emax model with baseline and shape factor.  Effect compartment. Run with FOCE-ELS

Webinar 9: PK/PD 1 Compartment-IV Infusion - Emax with Baseline, Shape and Effect

Probabilistic Model: A binary response versus measured concentrations, e.g. dose.

Webinar 10: Comparisons PD Categorical Response Analysis

Survival model (probablilistic) using the Laplacian engine

Webinar 11: Comparisons PD Time-to-Event Analysis

Count model, Poisson distribution.  Structural parameters of Loglambda and Coeff.  Random effect of 30% BSV on Loglambda

Webinar 12: Comparisons PD Count Analysis

Targe mediated drug disposition model with a single IV bolus dose and plasma concentrations of free drug only.

Webinar 13: TMDD Model translated from NONMEM (NM-TRAN) to Phoenix NLME (PML)

This is an archive of the NONMEM to NLME webinars that were presented during 2018. 

NONMEM to NLME Webinars

Simcyp Training

📙 Other Training Resources

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