Friday, 18 May 2007: 8:40 AM-12:05 PM
Auditorium (100) (Pfahler Hall)
Drugs: Manufacturing, Analyses and FDA Regulations
: The workshop is a forum for the presentation of the critical factors that determine consistent quality of pharmaceutical products, the science behind drug manufacturing process, appropriate analytical methods, evaluation of the science behind the regulatory requirements and recommendation of changes in the regulatory field. The invited speakers are from Academia, Industry and FDA. Topics intended to be covered by the Workshop are: - Current opinion on regulatory requirements for Drug Substances (Active Pharmaceutical Ingredients) - Critical factors in ensuring batch to batch consistency in drug product manufacturing, bioavailability and stability - Formulation, correlation of dissolution to bioavailability (in immediate release and extended release products), dissolution methods - Current FDA "Chemistry Manufacturing and Controls" (CMC) requirements, the rationale for the requirements (from industry / academia and regulators perspectives) - Critical factors missing in current CMC regulations, inclusion of which is recommended.
Organizer:Zelleka Getahun
Presider:Zelleka Getahun
8:40 AM Re-igniting our Commitment to Science and Technology: Education, Collaboration and Innovation!
Catherine T. Hunt
8:55 AM437Introductory Remarks
Zelleka Getahun
9:00 AM438Chemistry, Manufacturing, and Controls (CMC) Requirements for Multi-source (Generic) Drug Products: Up to the Task?
Richard C. Adams
9:40 AM439Leveraging Scientific Knowledge and Experience into Pharmaceutical Regulatory Submissions: An Analytical Perspective
James S. McElvain
10:20 AM Break
10:40 AM440Microenvironmental pH Modulation in Solid Dosage Forms: Chemical Stability, Dissolution, and Oral Absorption
Munir A. Hussain
11:20 AM441Development of a sensitive and reliable dissolution procedure for unconventional drug delivery systems
Reza Fassihi
12:00 PM Concluding Remarks

Back to The Middle Atlantic Regional Meeting (May 16 - 18, 2007)