Harmonization of rules in GLP and pharmacokinetic analysis: regulatory view
| Autor: | Tomasz, Grabowski, Monika, Marczak, Miroslaw, Muszynski, Muszynski, Miroslaw, Jerzy Jan, Jaroszewski |
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| Rok vydání: | 2012 |
| Předmět: |
Drug Industry
Drug-Related Side Effects and Adverse Reactions Computer science International Cooperation Clinical Biochemistry Drug Evaluation Preclinical Veterinary Drugs Harmonization Drugs Investigational General Medicine Pharmacology Analytical Chemistry Pharmacokinetic analysis Medical Laboratory Technology Risk analysis (engineering) Drug Discovery Practice Guidelines as Topic Animals Humans General Pharmacology Toxicology and Pharmaceutics Drug toxicity Drug industry |
| Zdroj: | Bioanalysis. 4:417-430 |
| ISSN: | 1757-6199 1757-6180 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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