bioequivalence
Infographic: Global Pharmaceutical Distribution
June 28 by Pharmaceuticals & Biotechnology EditorDespite global cost-cutting initiatives, over 82% of those working in the capacity of distribution expect their vendor investment budget to increase over the next 2 years. This...
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...
Relationship Takes Priority Over Cost for 66.7% of Firms Using CROs for BE/BA Studies
July 08 by Pharma IQThe value of teamwork has been increasingly recognised by pharmaceutical companies in recent times. Research has shown that around two thirds now outsource their bioequivalence and bioavailability (...
A Third of Bioequivalence and Bioavailability Experts Find the Ability to Secure Biowaivers a Main Concern, Says Recent Pharma IQ Survey
June 30 by Pharma IQ NewsPharma IQ has just published the results of an industry-wide Bioequivalence and Bioavailability Survey, conducted recently among 2,000 bioequivalence and bioavailability experts. The results show...
Change Control, You’d Better Have One!
June 14 by Cristina FalcãoWhile Change Control (CC) is applied to the entire chain of events in any pharma industry, from R&D to batch release, it is the core function of any pharmaceutical plant. “Even when a c...
Getting to Grips with the Estimation of Pharmacokinetic Parameters
October 27 by Pharma IQIn this interview Dr. Thomas Jaki, Lecturer from Lancaster University and expert in the estimation of pharmacokinetic (PK) parameters, speaks to Helen Winsor from Pharma IQ. He outlines the key i...
Boosting Bioavailability Through Partnerships
September 02 by Pharma IQIf the trends that have been seen in the pharmaceutical industry over the past few years prove anything, it is that drug development companies are increasingly recognising the value of teamwork. There...
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...
How to Build a Strong Strategy for Developing Biosimilars and Approach Bioequivalence Efficiently
July 19 by Pharma IQRichard Peck, Director for Regulatory Affairs at Finox, sums up the main challenges in developing biosimilars, including cost-cutting pressures and the need to take on board regulatory changes and tec...
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.
Strategies for Optimising Your Bioequivalence Studies
June 26 by Pharma IQPharma IQ caught up with Dr. Ole Østerberg, Clinical Research Scientist at NeuroSearch, ahead of the Bioequivalence and Bioavailability conference, taking place in Munich on the 26th-27th o...
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...