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Provide for each presentation (doses/vial), a list of the lots numbers on test, batch size, scale of production, vial size, vial orientation, and dates of manufacture.
Justification of the choice of these lots is requested.
Section A: Quality Overall Summary (QOS) To attach the Print Form (Section P – Product Information) once all the documents are completed prior to submission Section B: Table of Contents To prepare the Table of Contents based on completed Print Form (Section P – Product Information) Section C: Body of Data To attach the Print Form (Section P – Product Information) once all the documents are completed prior to submission The differences between clinical formulations and the formulation (i.e.
Composition) described in Item P 1 and P 2 should be discussed. dissolution) or comparative in vivo studies (e.g., bioequivalence) should be discussed when appropriate.
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