Clinical Research Guidelines
A companion to the
Textbook on Clinical Research:
A Guide for Aspiring Professionals and Professionals
Second Edition
By Dr. Guru Prasad Mohanta
 
Home | Indian Guideline | ICH Guideline | US FDA Guideline
ICH Guideline
 
ICH Safety Testing Guideline
      S1A Guideline on the need of carcinogenicity studies of pharmaceuticals    
      S1B Testing for Carcinogenicity of Pharmaceuticals    
      S1 (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    
      S3B Pharmacokinetics: Guidance for repeated dose tissue distribution studies    
      S4 Duration of chronic toxicity testing in animals (Rodents and Non-rodents Toxicity testing)    
      S5 (R2) Detection of toxicity to reproduction for medicinal products and toxicity to male fertility    
      S6 Preclinical safety evaluation of biotechnology derived pharmaceuticals    
      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 repolarisation (QT interval prolongation) by human pharmaceuticals    
      S8 Immunotoxicity studies for human pharmaceuticals    
      S9 Non clinical evaluation of anticancer pharmaceuticals    
      M3 (R2) Guidance on non clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals    
       
   
© 2017, Pharma Med Press                                   ISBN: 978-93-5230-166-9