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ratnakar1811 ★ India, 2016-03-10 08:13 (3755 d 02:44 ago) Posting: # 16082 Views: 7,345 |
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Dear Forum Members, Anybody has experience of conducting study for Medroxyprogesterone 150 mg IM injection? As per WHO around 124 subjects are required and a possible sampling scheme could be: pre-injection, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14, 16, 18, 21, 24, 28, 35, 49, 63, 77, 91, 105, 119, 140 days. From the above mentioned sampling scheme which is suggested in days, it is difficult to understand from which time point samples are to be collected in days? Is it from 28? Further do you feel looking at the PK data (linked with FDA, page 10) it seems sampling points suggested by WHO are inadequate? In addition to it study with USFDA where following sampling schedule was followed it seems over sampling is done that too in females: 0, 0.5, 1,2,3,4,6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240,264, 288, 312, 360, 432, 504, 576, 648, 816, 984, 1154, 1320, 1488, 1656, 1824, 1992, 2164, 2328, 2496, 2664, 2856 hrs. The PK data can be found (on page 10) Your valuable suggestions and comments are highly appreciated. Thanking you, Ratnakar |
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Dr_Dan ★★ Germany, 2016-03-10 10:11 (3755 d 00:46 ago) @ ratnakar1811 Posting: # 16084 Views: 6,030 |
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Dear Ratnakar The sampling schemes are more or less the same, WHO presents in days, FDA in hours. The only difference is a tighter sampling interval at day one in order to detect the initial peak suggested by the FDA and sampling twice per day for the first week suggested by WHO. I did a combination of both. I hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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ratnakar1811 ★ India, 2016-03-11 06:21 (3754 d 04:36 ago) @ Dr_Dan Posting: # 16089 Views: 5,954 |
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Dear Dr Dan, Thank you for your prompt reply, do you mean as per WHO all samples are in days which means initially every day there are only two samples till 7.5 days and subsequently only one sample post 8th day? I thought initial samples till 24 are mentioned in hrs and subsequent samples in days, I was wrong. But FDA submission study has 9 samples on day 1 (i.e. 0.5, 1, 2, 3, 4, 6, 8, 12, 24...) and rest 31 samples distributed over period of 140 days. Your view please. Thanking you, Ratnakar |
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Dr_Dan ★★ Germany, 2016-03-11 15:53 (3753 d 19:04 ago) @ ratnakar1811 Posting: # 16096 Views: 5,896 |
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Dear Ratnakar You are right, as per WHO all samples are in days , as per FDA in hours. The reason why PK Profil of the first day is evaluated: a) safety b) initial Peak. Hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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ratnakar1811 ★ India, 2016-03-14 09:20 (3751 d 01:37 ago) @ Dr_Dan Posting: # 16101 Views: 5,714 |
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Dear Dr_Dan, Thank you for your explanation and guidance. Thanking you, Ratnakar |
Ing. Helmut Schütz