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santosh.awale ☆ Mumbai, 2009-01-06 06:53 (6370 d 02:08 ago) Posting: # 2998 Views: 8,771 |
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Hi to all, we have one project, Sponsor want to conduct comparative pharmacokintics, In clinical part theire is no problem but statistically which parameter will be evaluated? which parameter to be compared? give your best suggesion.. Thanks and Regards.. Santosh A. |
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santosh.awale ☆ Mumbai, 2009-01-09 07:01 (6367 d 01:59 ago) @ santosh.awale Posting: # 3011 Views: 7,509 |
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hi to all, respected HS sir, i am waiting for your reply  , its very urgent, please suggest me statistical evaluation in comparative pharmacokinetic.(Which parameter to be evaluated Cmax Tmax, AUC. or ratio of this parameter?, i think it is not necessery to do 90% Confidence Interval because this study is not bioequivalence its comparative pharmacokinetic)Thank you, Regards,,, Santosh A. |
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JPL ☆ Vienna, 2009-01-09 10:28 (6366 d 22:32 ago) @ santosh.awale Posting: # 3013 Views: 7,464 |
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Dear Santosh, if you do not know anything about the way "comparability" should be demonstrated (what is stated in the protocol?) you may define the AUC0.tlast as the primary endpoint and AUC0-Inf, MRT, IR, ... as secondary ones. However, meaningful parameters depend on the application route. Then you calculate the points estimates and 95% CI for each parameter, and the ratio and the corresponding 90% CI for the ratio. If you do not provide any CI for the ratio, it is hard to evaluate whether a difference really exists. Regards, JPL |
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Helmut ★★★   Vienna, Austria, 2009-01-09 13:40 (6366 d 19:20 ago) @ santosh.awale Posting: # 3014 Views: 7,577 |
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Dear Santosh! ❝ i am waiting for your reply ^^ I don't like that one...  ❝ [...] its very urgent, [...] We give answers in our spare time. If it's urgent, you urgently will have to pay someone.  ❝ (Which parameter to be evaluated Cmax Tmax, AUC. or ratio of this parameter?, i think it is not necessery to do 90% Confidence Interval because this study is not bioequivalence its comparative pharmacokinetic) If the number of biostatisticians in the field = N, it's not unrealistic to expect >N+1 potential designs...If you don't give us a lot more informations, you will not get any answers. — 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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ElMaestro ★★★ Denmark, 2009-01-09 16:38 (6366 d 16:22 ago) @ santosh.awale Posting: # 3015 Views: 7,445 |
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Dear Santosh A., to me, comparative pharmacokinetics is bioequivalence in practice (although it could mean a lot of other things). Said this way simply because I have heard other people use that term when they really meant BE. I would guess that implies confidence intervals and AUC and Cmax and the whole shebang. Best regards EM. |
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Helmut ★★★ Vienna, Austria, 2009-01-11 13:59 (6364 d 19:01 ago) @ ElMaestro Posting: # 3017 Views: 7,506 |
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Dear ElMaestro! ❝ to me, comparative pharmacokinetics is bioequivalence in practice (although it could mean a lot of other things). A funny quote from Australia's TGA: Part 2 - Study Type Are you sure this is a bioavailability and/or bioequivalence YES NO study (and not a pharmacokinetic study)? A pharmacokinetic study concerns the properties of the drug whereas a bioavailability study concerns the properties of specific formulations or of different routes of administration. A food study is considered to be a bioavailability study. You are encouraged to contact the TGA to discuss studies if this is not clear for a given submission. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2009-01-13 15:14 (6362 d 17:47 ago) @ Helmut Posting: # 3025 Views: 7,395 |
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Dear HS, although I do not find that quote utterly clear, I would be inclined to say that comparative pharmacokinetics even in light of that wording would be BE. Best regards EM. |
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Helmut ★★★ Vienna, Austria, 2009-01-13 22:28 (6362 d 10:32 ago) @ ElMaestro Posting: # 3027 Views: 7,529 |
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Dear ElMaestro! ❝ [...] I do not find that quote utterly clear, Me not either... ❝ I would be inclined to say that comparative pharmacokinetics [...] would be BE. I would stick with EMEA's definition that a BE study is a comparative BA study, which is designed to demonstrate BE and the reference is the innovator's product. In BA we compare essentially the absorption, whereas for example in PK interaction studies also the clearance. IMHO there's an endless number of possibilities of comparing PK (interactions, disease states, covariates in PopPK like sex, age, creatine clearance, body weight, surface area,  ). That's why I aked for more informations about the rationale and design of Santosh's study.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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santosh.awale ☆ Mumbai, 2009-01-15 11:24 (6360 d 21:36 ago) @ Helmut Posting: # 3035 Views: 7,409 |
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Dear ElMaestro and HS sir, from your reply, i came to know that my data was not sufficient to ans. sponsor claims that his formulation is safe and non-abuse. then what will be statisticle parameter i have to evaluate? if EMEA's definition that a BE study is a comparative BA sudy, then what will be stat. evaluation? Regards.. Santosh A. |
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ElMaestro ★★★ Denmark, 2009-01-15 17:15 (6360 d 15:45 ago) @ santosh.awale Posting: # 3038 Views: 7,350 |
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Dear Santosh A., I don't think your description provides enough info to answer your question. What question is the sponsor asking and what drug are you dealing with? Design - has the sponser indicated anything to you what they had in mind? Best regards EM. |
Ing. Helmut Schütz