Any remaining metabolism studies that were not completed prior to Phase II
should generally be conducted prior to Phase III. Those ADME studies that are
commonly deferred to this stage of development may include:
- Placental transfer
- Milk secretion
- Studies in female animals (if earlier ADME studies were restricted to single gender only)
- Multiple dose studies to assess tissue accumulation (only where required - see ICH S3B)
- Human A(D)ME
All of the above-mentioned studies are conducted routinely by the Drug Metabolism department at Huntingdon Life Sciences. With regard to the latter item (human A(D)ME), we have over 30 years experience in conducting such studies in conjunction with one of our partner clinics and have conducted in excess of 200 such studies over this time by routes including oral, intravenous, topical, subcutaneous, intramuscular, intravaginal and rectal. Huntingdon Life Sciences holds a manufacturing licence under GMP and can prepare radiolabelled IMP's as required to GMP.
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