Good Clinical Practice eRegs & Guides - For Your Reference Book 6

Nonfiction, Health & Well Being, Medical, Reference, Drug Guides, Research

• Author: FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides a Biopharma Advantage Consulting L.L.C.
• ISBN: 1230000220524
• Publisher: Biopharma Advantage Consulting L.L.C.
• Publication: February 22, 2014
• Language: English

ICH - Safety Guidelines S1A – S9 

S1A Guideline on the Need for Carcinogenicity Studies 

S1B Testing for Carcinogenicity of Pharmaceuticals 

S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals 

S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use 

S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies 
Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies 

S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) 

S5(R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility 

S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals 

S7A Safety Pharmacology Studies For Human Pharmaceuticals 

S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals 

S8 Immunotoxicity Studies for Human Pharmaceuticals 

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals