The Analytical Partner You Trust
ADPEN Laboratories will be exhibiting at the Annual North American Chemical Residue Workshop (NACRW) to be held July 20-23, 2014 at the TradeWinds Island Grand in St. Pete Beach, FL. ADPEN continues our tradition of attending this very important annual meeting whose purpose is to “bring scientists together to develop and validate better methodologies.”
ADPEN will be exhibiting in Booth 38.
FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are about 50 such guidances planned. Below are a few highlights for the drug-manufacturing space.
In biopharmaceutics and biosimilarity:
• Food-Effect Bioavailability and Fed Bioequivalence Studies— Bioavailability and Bioequivalence Studies for Orally
Administered Drug Products Submitted in New Drug Applications General Consideration
• Scientific Considerations in Demonstrating Biosimilarity To a Reference Product (draft already issued)
• Quality Considerations in Demonstrating Biosimilarity To a Reference Protein Product (draft already issued)
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
(draft already issued)
In combination products:
• Development of Drugs in Combination
[Read more…]
Visit with ADPEN at Booth #36:
48th Annual Florida Pesticide Residue Workshop (FPRW)
July 17 – 20, 2011
TradeWinds Island Grand, St. Pete Beach, Florida