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vishal ☆ 2011-08-29 17:02 (5418 d 06:58 ago) Posting: # 7309 Views: 3,553 |
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Hi All, Can you help me, english version bioequivalence and other related guidelines for taiwan regulatory authority. regards vishal |
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yjlee168 ★★★ ![]() Kaohsiung, Taiwan, 2011-08-29 21:12 (5418 d 02:48 ago) @ vishal Posting: # 7311 Views: 3,037 |
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Dear Vishal, As far as I know, I don't think we have any BE/BA guidelines of English version released by Taiwan regulatory agency. But I will be very happy to help if you have any question about it. — All the best, -- Yung-jin Lee bear v2.9.6:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |
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vishal ☆ 2011-08-30 09:29 (5417 d 14:31 ago) (edited on 2011-08-30 22:40) @ yjlee168 Posting: # 7312 Views: 3,008 |
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yjlee168 ★★★ ![]() Kaohsiung, Taiwan, 2011-08-31 02:50 (5416 d 21:10 ago) @ vishal Posting: # 7314 Views: 3,052 |
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Dear Vishal, Yes, you can say that. But not entirely because it is kind of mixed guidelines from USFDA/EMA/Japan plus local scholars' opinions. Currently, we don't have BE guideline for HVDs yet. They still work on it. ❝ Is it inline with USFDA/EMEA guidelines. — All the best, -- Yung-jin Lee bear v2.9.6:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |

