Evotec is conducting preclinical and toxicology/safety studies for Stealth BioTherapeutics’ lead candidate, ahead of clinical trials slated to begin in 2019.
Description of the manufacturing process in regulatory submissions must be the same whether the applicants use Quality by Design (QbD) or the traditional approach, the FDA and EMA have concluded.
The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.
Scientists in research and academia have called for the end to the
pharmaceutical industry's 'cynical use' of drug studies and its
subjects who are often misled into taking part.
The contract manufacturing sector lagged behind the rest of the
outsourcing industry serving the pharmaceutical sector in 2004, but
there are encouraging signs for the future, reports Phil
Taylor.
