OR WAIT null SECS
November 09, 2006
AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes.
October 05, 2006
Rockville, MD (Oct. 2)-The US Food and Drug Administration has issued its final Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.
September 12, 2006
Washington, DC (Sept. 12)-The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here
September 02, 2006
As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.
June 22, 2006
Microsoft Corporation (Redmond, WA) announced the winners of the Microsoft Pharmaceuticals and Life Sciences Innovation Awards 2006 at this year?s meeting of the Drug Information Association in Philadelphia, Pennsylvania. A four-person panel of industry experts selected winners for the innovative use of Microsoft products in pharmaceutical and life sciences business processes and practices.
June 02, 2006
I always suspected that our purchasing manager had agreed to this just to save money . . .
April 02, 2006
Guidance for reducing the risk of dissolved ozone measurement and addresses proper installation, calibration, and verification to ensure the best possible answers from dissolved ozone analysis.
February 01, 2006
Though dissolution testing has been under scrutiny, it is still a powerful test method.
Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study.
January 01, 2006
Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.