title: Harmonization of rules in GLP and pharmacokinetic analysis: regulatory view.
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.
authors.affiliation: Polpharma Biologics ul. Trzy lipy 3, 80-172 Gdansk, Poland. tomasz.grabowski@polpharma.com
authors.forename: Tomasz
authors.initials: T
authors.lastname: Grabowski
authors.forename: Monika
authors.initials: M
authors.lastname: Marczak
authors.forename: Miroslaw
authors.initials: M
authors.lastname: Muszynski
authors.forename: Muszynski
authors.initials: M
authors.lastname: Miroslaw
authors.forename: Jerzy Jan
authors.initials: JJ
authors.lastname: Jaroszewski
mesh_terms: D000818:Animals; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D015507:Drugs, Investigational / Q000493:pharmacokinetics*; D006801:Humans; D007391:International Cooperation; D017410:Practice Guidelines as Topic / Q000592:standards*; D019155:Veterinary Drugs / Q000493:pharmacokinetics*
chemical_list: D015507:Drugs, Investigational; D019155:Veterinary Drugs