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THE PRINCIPLES OF ICH GCP
OPENING PLENARY SESSION
64 other sections not shown
acceptable adverse drug reactions adverse events analysis analytical procedures and/or animal application appropriate assay assessment batches bioassay biotechnology products carcinogenicity studies chemical Clinical Safety clinical studies clinical trials compounds conducted degradation products detection discussion document dosage forms dose-response draft drug development drug product drug substance duration efficacy EFPIA European European Union evaluation excipients Expert Working Group exposure factors genotoxicity guidance human identified IFPMA implementation important impurities industry investigator Investigator's Brochure issues Japan Japanese limits manufacturing marketing MEDDRA medicinal products methods micronucleus test patients pharmaceutical pharmacokinetic pharmacopoeias pharmacovigilance Phase potential protein protocol reached Step recommended registration regulators regulatory authorities relevant repeated dose requirements residual solvents rodent specific sponsor Stability Testing standards Steering Committee Table terminology three regions topic toxicity studies toxicokinetic toxicology treatment validation virus viruses vitro vivo