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- ICH Official web site : ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines
- ICH Official web site : ICH
The ICH Harmonised Guideline was finalised under Step 4 in February 2002 This document is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the main stability Guideline
- ICH Official web site : ICH
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years
- ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3)
The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities
- ICH Official web site : ICH
The ICH Harmonised Guideline was finalised under Step 4 in November 2003 This document provides a standardised procedure for post-approval safety data management and the guidance for gathering and reporting information
- STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS
g the principles outlined in ICH Q6A, Q6B and ICH Q8-Q11 When 331 designing a stability protocol in support of a drug substance or drug product, information on the CQAs 332 and the
- ICH Official web site : ICH
You can explore in the below table the index of all ICH Guidelines, finalised or under development, on the topics of Quality, Safety, Efficacy and Multidisciplinary
- ICH Official web site : ICH
In order to facilitate the implementation of the CTD General (M4) Guideline, the ICH Experts have developed a series of Q As The document which reached Step 4 of the ICH Process in June 2004, intends to clarify the key issues regarding the CTD
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