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Vardhan82 ☆ India, 2012-02-03 07:26 (5243 d 05:52 ago) Posting: # 8042 Views: 4,464 |
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Dear All, We have conducted Dose proportionality study for ANVISA submission, study was comfortably meeting the criteria. Hence, decided to submit same study to TGA by making the report in TGA format as well additional documentation required for TGA. The subjects were enrolled as per LIC for age and weight chart as the study planned for ANVISA. While compiling the data for making report for TGA, we came to know that some of the subjects were out of BMI range that is 17.65 to 31.43kg/m² (18.5 to 30 kg/m² as per TGA), But BMI criteria was not captured in the protocol. Whether TGA will accepts this data as the BMI is out of the range. But study is meeting the criteria. Thanks in advance for your help. Thanks, Vardhan |
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Helmut ★★★   Vienna, Austria, 2012-02-04 12:30 (5242 d 00:48 ago) @ Vardhan82 Posting: # 8053 Views: 3,540 |
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Dear Vardhan! ❝ […] While compiling the data for making report for TGA, we came to know that some of the subjects were out of BMI range that is 17.65 to 31.43kg/m² (18.5 to 30 kg/m² as per TGA), But BMI criteria was not captured in the protocol. ❝ ❝ Whether TGA will accepts this data as the BMI is out of the range. But study is meeting the criteria. I don’t think that this should be a major problem. IMHO no guideline exists concerning proportionality studies. TGA’s BE GL states: The inclusion/exclusion criteria should be clearly stated in the protocol. Subjects should be 18 years of age or older and preferably have a Body Mass Index between 18.5 and 30 kg/m². (my emphases)You have stated inclusion criteria in the protocol. The body height / mass range wasn’t the preferred one – but so what? Extreme values should not bother you in a cross-over design. Simply mention it in the report. — 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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Vardhan82 ☆ India, 2012-02-13 07:37 (5233 d 05:41 ago) @ Helmut Posting: # 8113 Views: 3,419 |
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Dear HS, Thank you for your reply. Thanks, Govardhan Pillari |
Ing. Helmut Schütz