Chiral or Achiral Bioanalytical method? [Bioanalytics]

posted by Petra – The Netherlands, 2012-06-01 18:15 (5139 d 08:43 ago) – Posting: # 8652
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One of our R&D products is a chiral compound. Only its S-enantiomer is present in the Investigational Medicinal Product (IMP). The S-enantiomer is the pharmacologically active enantiomer, the R-enantiomer is inactive.
  1. In case only one enantiomer (the S-enantiomer) is present in the IMP, and is the only enantiomer pharmacologically active, do we have to develop an achiral or chiral bioanalytical method?
  2. I have checked the literature to find any articles on metabolic conversion of the S- to the R enantiomer. Unfortunately, I could not find any articles which show that the chiral compound is metabolically stable. In fact, I did not find any literature on metabolic conversion for this compound. Does this mean (lack of literature) that we have to develop a chiral BA method?
  3. In the theoretical case I would have found literature which showed that metabolic conversion took not place between S- to R-enantiomer, would this have meant that an achiral method would suffice?

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