Related Experiment Video
Updated: May 24, 2026

A Bilingual Computational Workflow for Identifying Potential PLK1 Inhibitors in American Sign Language and English
Published on: April 3, 2026
Harmonization of rules in GLP and pharmacokinetic analysis: regulatory view
Tomasz Grabowski1, Monika Marczak, Miroslaw Muszynski
1Polpharma Biologics ul. Trzy lipy 3, 80-172 Gdansk, Poland. tomasz.grabowski@polpharma.com
Abstract:
This article is an attempt to present issues associated with the principles of GLP system harmonization, particularly in relation to pharmacokinetic (PK) studies at a global scale. Complete harmonization of GLP principles requires unification at several levels: inside registration authorities, between key registration authorities, within the framework of procedures regulating preclinical and clinical phases of the drug-development process and within the framework of procedures regarding GLP principles used in PK analyses and analyses of residuals of veterinary drugs. This large number of discrepancies indicates that total harmonization of rules on this issue will be very difficult and will require close cooperation between institutions responsible for legislative processes and control of GLP principles during PK analysis.
More Related Videos
08:59An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
08:31Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
Related Concept Videos
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Nonlinear Pharmacokinetics: Overview
Nonlinearity can arise due to the saturation of plasma protein-binding or...
Analysis of Population Pharmacokinetic Data
Dosage Regimens: Partial Pharmacokinetic Parameters
Pharmacokinetic Models: Overview
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal assumptions,...
Pharmacogenetics of Drug Metabolism: Overview