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Quality by design with a focus on biosimilars

Pharmaceutical Technology

OCTOBER 28, 2022

They inform industrial scientists what is necessary to ensure that their product meets the safety and efficacy requirements to get a product approved in humans. For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve.

Bioequivalency 130
Bioequivalency Production Branding Contamination 130
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Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

JANUARY 6, 2023

It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. In vitro release testing to demonstrate bioequivalence. Bioburden and microbial testing.

Production 130
Production Manufacturing Development Bioequivalency 130
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