Considerations for metabolite pharmacokinetic data in bioavailability/bioequivalence assessments. Overview of the recent trends.
In recent years, the assessment of metabolite pharmacokinetic data has been increasingly on the rise in several types of clinical pharmacology studies including bioavailability/bioequivalence assessments of drug formulations. While the importance of pharmacokinetic data of metabolite(s) are well accepted, there appears to be reluctance on the part of scientific community to use such data in a prospective manner in the establishment of bioavailability/bioequivalence of marketed products and/or drugs in development. This review highlights the current trends that suggest that metabolite(s) data are being considered with or without the parent pharmacokinetic data in bioavailability/bioequivalence studies with numerous case studies. Also, some useful considerations from both bioanalytical and pharmacokinetic perspectives are proposed.
Srinivas
Nuggehally R
NR
Integrated Drug Development, Suramus Biopharm, Bangalore, India. srini.suramus@yahoo.com
D001682:Biological Availability; D003627:Data Interpretation, Statistical; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000378:metabolism*; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency
D004364:Pharmaceutical Preparations