Global Drug Development Based on ICH-E5 Guideline.

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities), Step 3

ICH guidelines: inception, revision, and implications for drug development.

Since the inception of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) in 1990, six-party Expert Working Groups (EWG) have developed and revised numerous guidelines on preclinical safety evaluation (Table 1). The six parties to ICH represent the regulatory bodies and pharmaceutical manufacturing organizations in...

Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline.

The opportunity to write a truly international guideline on statistics is a rare one indeed. In 1995, the Steering Committee of the International Conference on Harmonisation1 (ICH) took a decision which was of major importance to all medical statisticians involved in the development of new medicinal products. This decision was to add a guideline on statistical methodology (E9) to the collection...

ICH guideline S10 - Guidance on photosafety evaluation of pharmaceuticals - Step 3

Inequality in the global prevalence of HIV based on the human development index

Background and aims: Burden of HIV and AIDS is considerably different among regions and countries around the world. The aim of this study was to assess the inequality in the prevalence of HIV, according to human development index worldwide. Methods: The desired outcome was prevalence of HIV, which was estimated in 100 countries in 2012. The annual report of Joint United Nations Programme on HIV...