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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. However, not all forward-looking statements contain these words. ” According to IQVIA, the U.S.

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Cerelle vs Cerazette: Are they really the same?

Druggist

Do generic, and branded drugs produce exactly the same effect? . Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). In terms of prescribing, both contraceptives are regarded as the same drug. . Cerelle vs Cerazette: are they the same?

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TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches. Cautionary Note on Forward-Looking Statements. Source link.