MULTIDISCIPLINARY GUIDELINES

ICH Multidisciplinary Guidelines from M1 to M14

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M1 MedDRA Terminology Guidelines

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M2 Electronic Standards Guidelines

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M3 Nonclinical Safety Studies Guidelines

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M4 Common Technical Document Guidelines

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M5 Data Elements and Standards for Drug Dictionaries

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M6 Gene Therapy Guidelines

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M7 Mutagenic Impurities Guidelines

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M8 Electronic Common Technical Document (eCTD) Guidelines

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M9 Biopharmaceutics Classification System-based Biowaivers

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M10 Bioanalytical Method Validation Guidelines

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M11 Clinical electronic Structured Harmonised Protocol

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M12 Drug Interaction Studies Guidelines

Sathyanarayana M.Sc. December 10, 2020

MULTIDISCIPLINARY GUIDELINES

ICH M13 Bioequivalence for Immediate-Release Solid Oral Dosage

Sathyanarayana M.Sc. December 10, 2020