Helmut ★★★ Vienna, Austria, 2004-10-05 21:04 (7371 d 03:12 ago) Posting: # 10 Views: 12,439 |
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Dear colleagues! Although it may be not a good idea to use 'old' studies for a regulatory submission – since scientific progress may be pretty fast – the only national guideline mentioning an 'Expiry Date' for a BA/BE study comes from South Africa, which states at 3.10 (page 13): 'The bioavailability/bioequivalence study should have been completed not longer than five years prior to the date of submission.' — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |