ANYL 406 |
| The ease of chiral separations relates to the amount of time spent in method development. Time is of the essence in this process. To save time, various important considerations should be addressed before and during method development. We know that drug discovery is generally initiated with the synthesis of a new chemical entity (NCE) or is based on natural or recombinant products. The molecular structure, including the presence of potential isomers of NCE, has to be determined early by a variety of techniques. Furthermore, it is necessary to demonstrate that an NCE is adequately pure and does not contain any undesirable enantiomer that exhibits any unusual pharmacologic, metabolic, carcinogenic, or genotoxic activity. Finally, it is necessary to select an optimum dosage form that meets therapeutic and marketing needs and is not susceptible to any transformations based on chirality. The selected clinical dosage form should meet GMP/GLP requirements and also must meet the quality standards filed in the IND or NDA. Discussion will focus on how method development is influenced by the above-mentioned considerations and a sound knowledge of various available approaches to chiral separations. It is necessary to have a strategy for method development that minimizes method development time, yet gives thorough consideration to selectivity, detectability, and analysis time. |
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Chiral Separations Made Easy
1:30 PM-5:00 PM, Wednesday, August 22, 2007 BCEC -- 104C, Oral
Division of Analytical Chemistry |