European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. 5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. The worldwide trend of using botanical drugs and strategies for developing global drugs.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

Pharmaceutical Technology

OCTOBER 28, 2022

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines.

Biosimilars 52

Biosimilars Vaccines Drug Development Documentation 52

Pharmaceutical Technology

APRIL 27, 2023

LNPs are an adaptable, modular technology and when combined with microfluidic mixing, have the potential to accelerate development and commercialisation timelines and provide drug developers with an early foothold into a largely untapped market.

Vaccines 52

Vaccines Drug Development Documentation Communication 52