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Amira Gouda ☆ Egypt, 2018-10-30 11:48 (2385 d 15:27 ago) Posting: # 19500 Views: 5,499 |
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Hi, Are subjects with deviations up to 10% in body mass index (for example: 31.5) eligible to be enrolled in bioequivalence studies? Thanks Amira Edit: Category changed; see also this post #1. [Helmut] |
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Ohlbe ★★★ France, 2018-10-30 12:42 (2385 d 14:33 ago) @ Amira Gouda Posting: # 19501 Views: 4,553 |
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Dear Amira, ❝ Are subjects with deviations up to 10% in body mass index (for example: 31.5) eligible to be enrolled in bioequivalence studies? Deviation from what ? What did you put in your protocol ? Either the BMI is within the limits set in the protocol and the subject is eligible, or the BMI is outside the limits and the subject is not eligible. Full stop. There is no bargaining. If your question relates to what limits should be put in the protocol: what is written in the guideline applicable to the country where your trial will be submitted ? If the guideline sets an upper limit of 30, then you should put that limit in the protocol. Again, no bargaining. A high BMI may not be problematic by itself on a PK or BE point of view, but you may have difficulties drawing the blood samples. — Regards Ohlbe |
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Amira Gouda ☆ Egypt, 2018-10-31 00:06 (2385 d 03:09 ago) @ Ohlbe Posting: # 19502 Views: 4,572 |
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Dear Ohlbe: I agree with you, we should strictly follow the study protocol, (NB: protocol BMI range: 18.5 - 30), but if principal investigator approved this deviation (31.5), recorded in protocol deviation log and submitted to IRB/IEC, what do you think? Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Ohlbe ★★★ France, 2018-10-31 00:48 (2385 d 02:26 ago) @ Amira Gouda Posting: # 19503 Views: 4,495 |
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Dear Amira, ❝ if principal investigator approved this deviation (31.5), recorded in protocol deviation log and submitted to IRB/IEC, what do you think? That it is still a protocol deviation, and non-compliance with ICH GCP sections 4.5.1 and 4.5.2. Unlikely to cause the rejection of the trial, but if there are too many of these, it may trigger questions and possibly an inspection. — Regards Ohlbe |
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ElMaestro ★★★ Denmark, 2018-10-31 10:19 (2384 d 16:56 ago) @ Amira Gouda Posting: # 19505 Views: 4,536 |
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Hi Amira Gouda, ❝ I agree with you, we should strictly follow the study protocol, (NB: protocol BMI range: 18.5 - 30), but if principal investigator approved this deviation (31.5), recorded in protocol deviation log and submitted to IRB/IEC, what do you think? On basis of my modest experience situations like this tend to arise out of bad planning when the CRO is running out of eligible subjects close the projected start of the study. That's the time when they start approving all sorts of deviations on BMI, blood sugar, ALAT/ASAT, HB/hematocrit and more in order to be able to meet the enrollment target and stay on time. You do not ever want to be confronted with questions going in that direction. What did the PI submit to the IEC/IRB and when exactly? — Pass or fail! ElMaestro |
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Amira Gouda ☆ Egypt, 2018-10-31 14:59 (2384 d 12:16 ago) @ ElMaestro Posting: # 19509 Views: 4,452 |
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❝ What did the PI submit to the IEC/IRB and when exactly? Hi, In such cases PI will submit to IEC/IRB before enrollment of the subject to BE study that he have for example one subject with deviation in BMI which is non significant to the trial and needed to complete sample size Thanks, Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
Ing. Helmut Schütz