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
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Indian Guideline
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ICH Guideline
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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