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ramesh_7779 ★ 2011-01-18 10:56 (5634 d 05:31 ago) Posting: # 6439 Views: 11,096 |
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Dear All, Can anyone clarify my doubt Is it necessary to conduct bioequivalence study for Medroxyprogesterone Acetate Injection 150 mg/mL in Postmenopausal Women. (or) It can be conducted in healthy female volunteer. (or) It can be conducted in healthy male volunteer. http://clinicaltrials.gov/ct2/show/NCT00381251 As the terminal half life of the drug is 50 days, how long one should collect the blood samples. Thanks & Regards Ramesh |
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pash413 ★ India, 2011-01-27 11:04 (5625 d 05:23 ago) @ ramesh_7779 Posting: # 6498 Views: 9,337 |
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dear Ramesh Please refer this link hope u may get all the answers http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004076553_S000_Medroxyprogesterone_BIOPHARMR.pdf Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Helmut ★★★   Vienna, Austria, 2011-02-09 17:29 (5611 d 22:58 ago) @ pash413 Posting: # 6604 Views: 8,957 |
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Dear Pash, your link is not working – did you make a typing error? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ramesh_7779 ★ 2011-02-10 12:56 (5611 d 03:31 ago) @ Helmut Posting: # 6611 Views: 9,138 |
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Dear helmut, Plz find the link below http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076553_S000_Medroxyprogesterone_BIOPHARMR.pdf If you are not getting plz go with google search. it available as "Clinical Pharmacology Biopharmaceutics Review(s) - CPY Document" Regards Ramesh Edit: URL working. Please use the Link -button at the right of the textarea to insert URLs in the future. [Jaime] |
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ramesh_7779 ★ 2011-03-25 06:59 (5568 d 09:29 ago) (edited on 2011-03-28 12:21) @ ramesh_7779 Posting: # 6811 Views: 8,795 |
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Dear All, Is it necessary to collect blood sample for 119 days (BE study medroxyprogesterone) as per the link? Regards Ramesh Edit: Follow-up post (28 March) deleted. Relax and read the Policy in the meantime. BTW, a link in {curly brackets} will not work. [Jaime] |
Ing. Helmut Schütz