PBPK/PD Modeling — Hands-on

Learn end-to-end PBPK/PD modeling to translate in vitro and preclinical findings into clinically relevant predictions. This hands-on module covers compartmental vs PBPK structures, IVIVE and allometric scaling, parameter estimation (nonlinear mixed effects) , covariate modeling, and simulation-based decision making for dose and regimen selection — delivered as reproducible workflows.

PBPK/PD Modeling Fundamentals for Drug Development

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Session Index

Session 1 — PK/PD Basics, Data & Assumptions Session 2 — Compartmental vs PBPK & IVIVE Session 3 — Parameter Estimation, PopPK & Covariates Session 4 — Mini Capstone: Scenario Simulations & Dosing

Session 1

Fee: Rs 19800

PK/PD Basics, Data & Assumptions

Core concepts & study designs

PK vs PD, exposure–response noncompartmental analysis (NCA) sampling designs & BLQ handling

Data requirements & QC

concentration–time, bioanalytical QC units & dosing records EDA & outlier strategy

Toolchain

R (nlmixr2/mrgsolve) Stan/TMB PK-Sim/OSPSuite

Session 2

Fee: Rs 22800

Compartmental vs PBPK & IVIVE

Structural model choices

one/two-compartment (+ effect site) PBPK organ flows/volumes permeability & binding

Scaling & IVIVE

allometry (CL, V) in vitro → in vivo (microsomes/hepatocytes) first-pass & absorption models

PD link models

Emax/sigmoid Emax indirect response models turnover & transit compartments

Session 3

Fee: Rs 25800

Parameter Estimation, PopPK & Covariates

Fitting strategies & diagnostics

FOCEI/SAEM/Bayesian residuals, GOF, VPC bootstrap & shrinkage

Population variability & covariates

inter-/intra-subject effects age/weight/renal/hepatic DDI & formulation effects

Model reporting & reproducibility

model file/version control unit tests/simulation checks model/decision cards

Session 4

Fee: Rs 29800

Mini Capstone: Scenario Simulations & Dosing

Design simulations for decision support

Theory + Practical

What-if scenarios & dose optimization

DDI, renal/hepatic impairment pediatrics/geriatrics target attainment, PTA/T>MIC

Deliverables

simulation notebook & config VPC/GOF plots & report dose/regimen recommendation

PDF

PBPK/PD Modeling Fundamentals for Drug Development | IVIVE, PopPK & Simulation-Driven Dosing

PBPK/PD Modeling — Hands-on