Module 5 Presentations

05/07/2024

Trial Phases & Resulting Changes - DS

Phase I

Phase II

Phase III

S.4 Specifications S.4.3 Validation of Analytical Procedures

Review and revise between phases based on relevant parameters

Batch results

Preliminary spec.

Final spec.

Suitability of method confirmed . Limits and parameters tabulated All batches used in non-clinical studies and any clinical batch

Suitability of method demonstrated . Tabulated summary of validation studies

S.4.4 Batch Analysis

Non-clinical and clinical batches Comparison / justification of changes

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Trial Phases & Resulting Changes - DP

Phase I

Phase II

Phase III

P.2 Pharmaceutical Development P.3.4 Controls of Critical Steps and Intermediates

Where formula/dosage form changes, relevance of earlier material to current DP to be discussed

Critical manufacturing steps, their controls and intermediates to be documented. Stored intermediates require assurance of appropriate storage conditions/ duration

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