Bioequivalence and Bioavailability Forum

krishna tiwari ☆ India, 2016-04-16 09:05 (3262 d 21:37 ago) Posting: # 16208 Views: 4,158	BMI criteria in ANVISA regulatory requirements [Regulatives / Guidelines] Post reply
	Dear All good morning, please suggest to me what is body mass index (BMI) inclusion criteria to enrolled the study in ANVISA regulatory requirements.

Helmut
★★★

Vienna, Austria,
2016-04-18 15:44
(3260 d 14:57 ago)

@ krishna tiwari
Posting: # 16212
Views: 3,300

No BMI but “normal weight”

Post reply

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%;

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felipeberlinski ☆ Brazil, 2016-04-25 23:01 (3253 d 07:41 ago) @ Helmut Posting: # 16238 Views: 3,085	No BMI but “normal weight” Post reply
	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]

BMI criteria in ANVISA regulatory requirements [Regulatives / Guidelines]

No BMI but “normal weight”

No BMI but “normal weight”