ICH Q8 (R2) Pharmaceutical development

Table of contents

This document describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.

Keywords: Pharmaceutical development, quality, quality by design, enhanced approach, design space, proven acceptable ranges, process analytical technology, risk assessment, control strategy

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