Pharmaceutical Technology, July 2023

Gaining a Deeper Understanding of Aseptic Needs

July 03, 2023

Cover Story

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To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

July 03, 2023

Peer-Reviewed Research

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FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

Top 10 Considerations when Meeting with Regulators

July 02, 2023

Quality/Regulations

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Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.