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). 2015; 13:8-17. Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec].

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

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.

Food and Drug Administration 96

Food and Drug Administration Pharmaceutical products Pharmaceutical FDA 96

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. Tony Cundell: Perhaps the second greatest challenge is the ongoing transition from products based on small molecules to large molecules to cellular therapies.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

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. Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52