European Pharmaceutical Review

FEBRUARY 1, 2024

For at least a decade from 2013 until recently, LDL lowering treatments were stuck on a paradigm of just putting people on statins and not getting LDL levels down to certain goals” CETP inhibitors have been around for a while, but they have unfortunately been unsuccessful in getting onto the market commercially. “For

Pharma 97

Pharma Patients Pharmaceutical Leads 97

European Pharmaceutical Review

DECEMBER 19, 2023

TRS 953 – Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products: Stability conditions for WHO Member States by Region. Injection Safety Fact Sheet. 2011;29:7122–7124. Sharma D, Khamar S, Cullen A, et al. Innovative Drying Technologies for Biopharmaceuticals.

Distribution 111

Distribution Manufacturing Food Pharmaceutical 111

European Pharmaceutical Review

JANUARY 16, 2023

The safety and efficacy of mRNA vaccines should be a game changer and is the likely solution to antibiotic-resistant microorganisms and emerging viral pathogens.” The other side is the pipeline of new pharmaceutical products. About the authors.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

European Pharmaceutical Review

APRIL 8, 2025

One element that project managers often forget or underestimate is the environmental, health and safety (EHS) tasks” Operating PAT from hardware to software, in a manufacturing suite, would not be successful without training and competency development to track training status in a learning management system for individuals. Lezotre PL.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52

European Pharmaceutical Review

DECEMBER 23, 2024

14 This in turn has led to the introduction of safety-based limits, 15 eg, permitted daily exposures (PDEs), etc. ICH Q6A 1 states that specifications should focus on those characteristics found to be useful in ensuring the safety and efficacy of the drug substance and drug product. EMA/CHMP/ICH/353369/2013. 4 March 2020.

Safety 52

Safety Pharmaceutical Manufacturing Management 52