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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

The GAMP 5 Second Edition also provides a great deal of encouragement for regulated companies to leverage vendor documentation, stating “…testing may occur both in the vendor’s development life cycle and in the regulated company’s implementation life cycle”. FDA, 2022. . About the authors.

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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

Gregory’s industrial career spans an employment history with several major pharmaceutical companies. IPQ International Pharmaceutical Quality. 2002; 74(8): 1760–71. Cited 2023Feb]. Available from: [link] Egelhofer V, Gobom J, Seitz H, et al. Protein identification by MALDI-TOF-MS peptide mapping:  a new strategy.

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Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

PharmaShots

Shots: Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versions Like every other utility patent, pharmaceuticals also get market exclusivity of 20 years. The exact mechanism of action is uncertain.

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Cyltezo vs. Humira: Differences, similarities & side effects

The Checkup by Singlecare

Humira is a brand-name medication made by the pharmaceutical company AbbVie, Inc. Cyltezo is an interchangeable biosimilar (similar to a generic, but for biologic drugs like Humira) made by Boehringer Ingelheim Pharmaceuticals, Inc. Humira is a biologic drug and a monoclonal antibody that the FDA approved in 2002.

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How much is aripiprazole without insurance?

The Checkup by Singlecare

Aripiprazole is the generic version of Abilify, which was developed by Otsuka Pharmaceutical Company and Bristol Myers Squibb and approved by the Food and Drug Administration (FDA) in 2002. Generic medications are FDA approved and work the same as their brand-name equivalents. Is there a generic for aripiprazole?