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Ken Peh ★ Malaysia, 2014-04-13 06:41 (3664 d 10:53 ago) Posting: # 12826 Views: 2,871 |
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Dear All, Would appreciate your input. An example on inclusion criteria.
In (II), both male and female must be recruited and enrolled. What should be the right approach ? Is it essential to provide detailed information in BE study protocol ? If we only recruit male subjects, we need to write healthy male subjects ?  Thank you. Regards, Ken Please don’t write “RE: ” in the subject line; removed. [Helmut] |
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ElMaestro ★★★ Denmark, 2014-04-13 11:52 (3664 d 05:43 ago) @ Ken Peh Posting: # 12829 Views: 2,563 |
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Hi Ken Peh, ❝ I. Healthy subjects, 18-55 years of age. ❝ II. Healthy male and female subjects, 18-55 years of age. ❝ ❝ In (I), either sexes or both sexes can be used. In the event that we are not able to recruit or enroll female subjects, we can enroll 100% male subjects and the study can still proceed. ❝ What should be the right approach ? (...) If we only recruit male subjects, we need to write healthy male subjects ? I think this is a technicality. If you manage only to enroll males then I guess both (I) and (II) can be considered fulfilled (perhaps I'd write male or female subjects in (II)). For an ordinary product which is not linked to any sex I can't imagine this issue will stand in your way, to be honest. — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2014-04-13 14:31 (3664 d 03:04 ago) @ Ken Peh Posting: # 12830 Views: 2,535 |
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Dear Ken, If you plan to only have male subjects in the study, I think you should write it clearly in the protocol. ❝ In (II), both male and female must be recruited and enrolled. Yes, I think it could be interpreted that way. If the study is for FDA submission that's what they would expect anyway. In the EU male-only studies are accepted (and actually common practice). ❝ I. Healthy subjects, 18-55 years of age. May be safer if you're not sure to be able to get females too. — Regards Ohlbe |
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Ken Peh ★ Malaysia, 2014-04-14 08:12 (3663 d 09:22 ago) @ Ohlbe Posting: # 12831 Views: 2,502 |
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Dear Ohlbe, Thank you for your input. ❝ Yes, I think it could be interpreted that way. If the study is for FDA submission that's what they would expect anyway. In the EU male-only studies are accepted (and actually common practice). Do you mean FDA enforces the use of both sexes in BE studies ? Our local regulatory agency raised this question. We were asked why used only male subjects as FDA states that both male and female can be used in the study. Our reason given is similar to what Helmut has posted before. The use of male reduces variability and we do not have to worry about the monthly hormonal changes of the female subject. The problem arises mainly because of the different interpretation. We interpret that male and female subject can be used, whereas regulatory officer interprets that both male and female must be used. Regards, Ken |
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kvgreddy06 ☆ India, 2014-04-14 15:01 (3663 d 02:34 ago) @ Ken Peh Posting: # 12834 Views: 2,475 |
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Dear All, Can we write like healthy male and/or female subjects, so that we can include based one the availability of subjects, 1. only males or 2. male and female share your ideas... Thanks venugopal |
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jag009 ★★★ NJ, 2014-04-14 17:40 (3662 d 23:55 ago) @ Ken Peh Posting: # 12837 Views: 2,545 |
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Hi Ken Yes we always run studies with M and F for FDA (unless they specify no females). However, they do not enforce equal ratios (50/50). In the protocol we state something like M and F to be enrolled and will make an effort to recruit equal number of Ms and Fs. John |
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Helmut ★★★   Vienna, Austria, 2014-04-15 15:50 (3662 d 01:45 ago) @ jag009 Posting: # 12841 Views: 2,433 |
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Hi John, ❝ In the protocol we state something like M and F to be enrolled and will make an effort to recruit equal number of Ms and Fs. Good idea! In the – not so recent – past a large German CRO managed it to recruit 15 males and one female. Bizarre. — 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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lechia ☆ C of U, 2014-04-24 19:00 (3652 d 22:35 ago) @ Helmut Posting: # 12892 Views: 2,360 |
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❝ Good idea! In the – not so recent – past a large German CRO managed it to recruit 15 males and one female. Bizarre. I've seen this on a number of occasions. However, in today's world there's a twist to think about. We had a situation where someone who was a male but became a female (or the other way around, can't remember) tried to enroll in a study. In the end the sponsor vetoed the inclusion, though I'm not sure on what basis (this was not a BE study). |
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Mahesh M ★ India, 2014-04-14 16:06 (3663 d 01:29 ago) @ Ken Peh Posting: # 12835 Views: 2,454 |
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Dear Ken, If a drug product is intended for use in both sexes, the applicant should include similar proportion of males and females in the study. (As per Guidance for Industry Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” And it is always better to describe clearly in the protocol about study population. So if you enroll male subjects only then mentioned Adult healthy male And if both male and female subjects will enroll then mentioned adult healthy male and female Regards Mahesh |
Ing. Helmut Schütz