European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They detail the medication’s intended use, proper administration, potential side effects and precautions. percent as EU average with some Member States as high as 25 percent).

Healthcare 84

Healthcare Healthcare Electronics Safety 84

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Safety 113

Safety Medicine Competition Networking 113

Pharmaceutical Technology

FEBRUARY 23, 2023

The SDD tablet had the highest exposure, but the micronized capsule was selected for progression, as C max was lower (which could be advantageous for C max -related side effects), AUC was similar, and commercial progression of a micronized capsule formulation is easier and cheaper than an SDD formulation. S54 – S61 (2001).

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical Food Side effects 98