Posts

Showing posts with the label Q1A(R2)

ICH GUIDELINE FOR STABILITY TESTING

Image
·          Describes regarding sampling times, storage conditions& specific test parameters for each dosage form. ·          The FDA & The expert working group of the ICH of technical requirements for the registration of pharmaceuticals for human use have published guidelines for conducting the actual studies. ·          ICH guideline as follow, o    Quality Guidelines “Q” (chemical and pharmaceutical QA) o    Safety Guidelines “S” (in vitro and in vivo pre-clinical studies) §   covering Carcinogenicity Testing, Genotoxicity Testing, §   Toxicokinetics and Pharmacokinetics ….. etc. o    Efficacy Guidelines “E” (clinical studies in human subject) §   Covering clinical safety, Dose Response Studies, Good  §   Clinical Practices, Clinical evaluation …. etc. o    Multidiscipl...

Popular posts from this blog

Introduction of Latin to English, weights and measures in dispensing pharmacy

PATIENT RELATED FACTORS AFFECTING ON DRUG ABSORPTION

PLANT LAYOUT FOR CAPSULE MANUFACTURING DEPARTMENT & MANUFACTURING PROCESS

Facebook Page