bioequivalence studies
One Year On: The Bioequivalence Guidelines
July 20 by Helen WinsorHelmut Schuetz of BEBAC Consultancy and Anders Fuglsang of Fuglsang Pharma Consultancy, join Pharma IQ to discuss the impact of the bioequivalence guidelines introduced in summer 2010 on the pharmac...
Challenges and Changes in Bioequivalence Studies
August 15 by Pharma IQHelmut Schutz, CEO of BEBAC, joins Helen Winsor from Pharma IQ, to talk about the challenge of sample sizes in bioequivalence studies. The interview explores the idea of literature data versus pilot s...
Cross-Validation of Bioanalytical Methods: When, Why and How?
July 05 by Pharma IQBioequivalence studies are extremely important for the pharmaceutical industry to ensure that generic drugs are up to standard, and make their way to the market in a timely manner.
Implementing New Guidelines to Optimise Bioequivalence and Bioavailability Studies
June 22 by Pharma IQ NewsTwo thirds of clinical studies worldwide are bioequivalence studies, so who can afford not to be up to date with the latest guidelines? Companies need to leverage these regulations to ensure effic...
Guidelines are Not Recipes: Biowaivers and Beyond
March 29 by Anders FuglsangAhead of the 2nd Annual Bioequivalence and Bioavailability Studies conference, Pharma IQ caught up with Anders Fuglsang from FuglsangPharma. Fuglsang is a former EU regulator (clinical asses...
Addressing the Challenge of Sample Size in Bioequivalence Studies
March 29 by Helen WinsorHelmut Schütz, CEO of BEBAC, joins Pharma IQ to discuss challenges and changes in bioequivalence studies. To listen to the podcast now go to Challenges and Changes in Bioequivalence Studies....