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pash413 ★ India, 2011-10-15 17:31 (5373 d 01:34 ago) Posting: # 7497 Views: 2,960 |
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Dear All As per EU guideline following is the criteria for parallel design study. “In parallel design studies, the treatment groups should be comparable in all known variables that may affect the pharmacokinetics of the active substance (e.g. age, body weight, sex, ethnic origin, smoking status, extensive/poor metabolic status). This is an essential pre-requisite to give validity to the results from such studies.” We are planning to conduct a parallel study for EU submission. Please advice how can we minimize these variables and make uniform distribution of volunteers between two parallel group for such bioequivalence study to reduce the variability in result because of above mentioned active substances. thanks |
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Helmut ★★★   Vienna, Austria, 2011-10-15 18:38 (5373 d 00:27 ago) @ pash413 Posting: # 7498 Views: 2,513 |
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Dear Pash! ❝ […] how can we minimize these variables and make uniform distribution of volunteers between two parallel group for such bioequivalence study to reduce the variability in result […] Which point of the guideline do you not understand? Standardize as far as possible for covariates which might influence the plasma concentration. If your drug is subjected to polymorphism, this is likely the most important factor. ![[image]](img/search.png) Search the forum!❝ […] because of above mentioned active substances. You did not mention any substance. — 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, 2011-10-15 19:20 (5372 d 23:45 ago) @ pash413 Posting: # 7499 Views: 2,364 |
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Hi pash413, further to the post from HS, I think you can safely say that a randomisation table is your friend. Using it, you wouldn't want to ever be without it, helps level out differences between subjects and thereby groups. EM. |
Ing. Helmut Schütz