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balakotu ★ India, 2014-07-02 10:50 (4377 d 01:15 ago) Posting: # 13200 Views: 3,395 |
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Dear All, What are the studies required for Nevirapine Extended Release tablets for Europe regulatory? Strengths available are 50 mg, 100 mg, 400 mg. Since product is single unit Extended Release Tablet, as per guidelines single dose fasting studies for 50 mg, 100 mg and 400 mg are required. Single dose Fed study for 400 mg and Multiple dose fasting study on 400 mg required. Upon multiple dose administration, risk of Nevirapine toxicity in healthy volunteers (May be for all strengths also). If multiple dose study in HIV patients, may need to give other ARV’s as a concomitant medication. Please suggest the multiple dose study in this case. Regards Kotu. |
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Ohlbe ★★★ France, 2014-07-04 18:16 (4374 d 17:49 ago) @ balakotu Posting: # 13217 Views: 2,607 |
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Dear Kotu, I deleted your duplicate message posted today. Please check the forum policy: If you feel that your post did not gain the attention you expected, you may reply to your own post in order to bring the thread back to the top of the forum. A reasonable waiting period is two weeks or if the thread has left the entry page of the forum. Only one ‘reminder’ is suggested; consider the possibility that nobody has an answer or is not willing to share his/her experiences. Further ‘reminders’ are discouraged and may lead to locking the thread by moderators or the administrator. Remember that all forum participants post during their free time. If you are in a hurry: consider hiring a consultant. — Regards Ohlbe |
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balakotu ★ India, 2014-07-05 13:42 (4373 d 22:23 ago) @ Ohlbe Posting: # 13218 Views: 2,643 |
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“If proposed strength is only 400 mg strength, what is the available option for multiple dose study”? |
Ing. Helmut Schütz