Dr Raman (Ray) Baweja (FDA) and Dr Abdul Basit (University of London) will speak at the next meeting of the Indiana-Ohio AAPS Discussion Group (IODG). Networking starts at 5 PM, followed by dinner and the talk. The meeting will be at the Kingsgate Marriott in Cincinnati. Additional details will soon be available at http://aaps.org/inside/Discussion_Groups/IODG/index.asp.
AAPS is the American Association of Pharmaceutical Scientists.
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Question for Dr. Baweja:
With concerns as a pharmacist-advocate for my patients in rural Indiana, may you please discuss briefly in your view, the largest influence in the current drug safety ‘environment’ in the US, based on your extensive scientific investigative career in FDA?
Please reflect on the past 25 years, beginning with exhaustive research in developing technological criteria for establishing biopharmaceutical equivalence of sustained action oral respiratory medications, to helping with establishment of production standards for biological source drug products and points between, in the current atmosphere of widespread use of questionable source drugs, with factors such as the impact of pharmacokinetic emergence of antimicrobial resistance and other barriers to effective drug therapy suggested by human biological changes over the quarter of century (genetic influence of enzymatic elimination processes, immunological influences (e.g. greater prevalence of DM2 and other human pathophysiological changes) and increasingly powerful political factors favoring less adherence to strict standards.
Thank you.
Cathy,
I’m not Dr. Baweja but will forward your comments to those who can help answer your questions.
Thank you,
Jon Speer