ICH Q8 (R2) Pharmaceutical development

Table of contents

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

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