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krishna tiwari ☆ India, 2016-04-16 09:05 (3722 d 14:32 ago) Posting: # 16208 Views: 5,067 |
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Dear All good morning, please suggest to me what is body mass index (BMI) inclusion criteria to enrolled the study in ANVISA regulatory requirements. |
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Helmut ★★★   Vienna, Austria, 2016-04-18 15:44 (3720 d 07:52 ago) @ krishna tiwari Posting: # 16212 Views: 4,029 |
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Hi Krishna, please see this post #3. ❝ please suggest to me what is body mass index (BMI) inclusion criteria to enrolled the study in ANVISA regulatory requirements. ANVISA’s website is a mess (it is very difficult to find anything if you don’t know Portuguese). The latest version I have (April 2006) states in Section 1. Etapa clínica l) o peso dos voluntários deverá estar em um limite de ±15% do peso considerado normal para homens e mulheres, levando-se em consideração altura e estrutura física. No caso de contraceptivos, recomenda-se que o limite de peso seja de ±10%; — 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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felipeberlinski ☆ Brazil, 2016-04-25 23:01 (3713 d 00:35 ago) @ Helmut Posting: # 16238 Views: 3,823 |
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Hi Helmut You are right about ANVISA guidelines, and there is no statement about exactly BMI. Just to facilitate Krishna's life, we are using BMI 18.5 – 29.9 kg/m2, inclusive and no complaints from ANVISA so far. Edit. Two posts merged. Please see this post #5. [Helmut] |
Ing. Helmut Schütz