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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. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. What is a Biosimilar?

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Clinical Catch-Up: December 21-25 | BioSpace

The Pharma Data

The drug is a humanized IgG4 monoclonal antibody that blocks CCR5 and is being developed for COVID-19, HIV and metastatic triple-negative breast cancer. The drug is a topical ointment applied to the lower lid to address the build-up and shedding of proteins at the opening of the Meibomian gland. Non-COVID-19-Related.

Trials 52
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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound.