Process Research in the Pharmaceutical Industry: The Design and Development of Practical Syntheses
| Type | Course |
|---|---|
| Language | English |
| Date |
April 7, 2008
to April 8, 2008 |
| Venue |
Sheraton at Woodbridge Place Hotel 515 US Highway 1 South Iselin, New Jersey 08830 US |
| Chemistry Specialties |
|
| Chemistry Techniques |
|
| Contact |
ACS 1155 Sixteenth Street, NW Washington, DC , 20036 US 1-800-227-5558 ext. 4508 202-872-6336 service@acs.org |
| Add event to calendar |
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This course on pharmaceutical process research will focus on the design and development of practical syntheses for product candidates. The importance of combining synthetic organic chemistry with physical/mechanistic organic chemistry and innovation is stressed. It is designed to expose participants to all phases of drug process development from preclinical to New Drug Application filing. Numerous examples will be used to illustrate key aspects of process research, including issues related to U.S. Good Manufacturing and Good Laboratory Practices (cGMP/GLP) as well as those related to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Real life examples will address creativity, timeline, economic, environmental, analytical, formulation, final form, cGMP, impurity and regulatory issues.
