European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). 2016; 85(4):2048-2050. 2016; 12(7):878. Tuijin Jishu / Propuls. cited 2023Dec].

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Time for change. Free Webinar.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical products Manufacturing Pharmaceutical 52

European Pharmaceutical Review

OCTOBER 19, 2022

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment.

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Food and Drug Administration Pharmaceutical products Pharmaceutical FDA 96

European Pharmaceutical Review

FEBRUARY 3, 2025

The US Food and Drug Administration (FDA) has sent a warning letter to KVK-Techs drug manufacturing facility following an inspection in April 2019. The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.

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Manufacturing Food and Drug Administration FDA Food 88

European Pharmaceutical Review

APRIL 8, 2025

They should remain informed, knowledgeable of the PAT, monitor compliance regularly, especially if PAT is directly involved in drug substance production and the instruments are product-contact and in the regulatory filing dossier. Good Design Practices for GMP Pharmaceutical Facilities. References 1. Bliesner DM.

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Manufacturing Food and Drug Administration Management Pharmaceutical 52