Module 5 Presentations

05/07/2024

Trial Phases & Resulting Changes - DP

Phase I

Phase II

Phase III

P.5.1 Specifications

Limited specification

At least batch results

Spec. set in earlier phases to be reviewed and adjusted as appropriate. Suitability of method demonstrated . Tabulated summary of validation studies

Suitability confirmed P.5.3 Validation of Analytical Procedures

Initial batch results, likely limited

Additional clinical batches Comparison / justification for changes. Data from additional sites

P.5.4 Batch Analysis

11

Trial Phases & Resulting Changes - DP

Phase I

Phase II

Phase III

Brief justification of specification

Choice of specs and acceptance criteria that may be relevant to efficacy/safety to be justified

P.5.6 Justification of Specification(s)

Confirm ongoing stability study with relevant batches. Confirm prior to CT, accelerated and long term studies initiated. Summarise available data and use development data.

Evaluation of the data and assessment of shelf-life based on clinical batches. Stability should be based on accelerated and long term condition as per ICH Q1A

P.8 Stability

12