Drug Product

August 13, 2020
Published by Meranda Parascandola at August 13, 2020

The Odd Couple – Part 7: Authoring the Composition and Pharmaceutical Development Modules

Pharmaceuticals (both Synthetically and Biotechnology-derived) are being developed by many sponsors whose management teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products.
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August 5, 2021
Published by Meranda Parascandola at August 5, 2021

Why and When Filter Validation is Key to Bringing a Product to Market

Bringing a product to market is a long and complex one, even more so when developing a sterile product, such as injections, ophthalmic preparations, irrigation fluids, dialysis solutions, among others. The only method for removing microorganisms without adversely affecting the product is sterile filtration, and those processes need to be assessed through filter validation to ensure that the filter used to eliminate any microorganisms is the right one.
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September 2, 2021
Published by Meranda Parascandola at September 2, 2021

Planning, Preparing and Crafting the Drug Development Report

DSI has seen a lot of pharmaceutical development reports ranging from several hundred pages to a summary of conclusions attached to stacks of data. The latter can make things difficult when it’s time to put a regulatory filing together. It’s become clear that capturing development decisions and data from the outset in a living document is good practice and whether the data collected thus far is supporting development goals. It’s a reference point for what has been completed and what still has to be done.
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April 6, 2022
Published by Meranda Parascandola at April 6, 2022

Nitrosamine Assessment

The FDA has been investigating the presence of nitrosamine impurities in certain drug products. Since 2018, several drug products including ARBs, ranitidine, nizatidine, and metformin have been found to contain unacceptable levels of nitrosamines. Nitrosamines are classified as probable human carcinogens based on animal studies and there has been a pressing need to remove the risk to patients.
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