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pash413 ★ India, 2014-04-09 09:45 (4107 d 10:48 ago) (edited on 2014-04-09 12:39) Posting: # 12797 Views: 5,117 |
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Hello, My question is for drugs where dosing is to be done based on the body weight/Body surface area (BSA) etc Below are my doubts [1] Say we are doing a 2 way cross over study for these molecules with a washout of 30 days and subject lost/gained weight meanwhile. Because of this the dose administered (amount of drug) in both the periods will be different. Can this subject be considered for BE analysis  The reason for asking this question is because basic definition of BE would be violated if subject is included. As per USFDA’s definition of BE “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. [2] If your answer for above question is yes do we need to do the dose normalization to account for difference in the dose administered (like Cmax/Dose or any other derivatization of PK metrics).[3] What to do if my study is parallel??? Because the dose administered to subjects in both the cohorts will be different |
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luvblooms ★★ India, 2014-04-10 08:32 (4106 d 12:01 ago) @ pash413 Posting: # 12803 Views: 4,214 |
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Hi ❝ My question is for drugs where dosing is to be done based on the body weight/Body surface area (BSA) etc ❝ ❝ [2] If your answer for above question is yes do we need to do the dose normalization to account for difference in the dose administered These points were discussed in this post. ❝ [3] What to do if my study is parallel??? Because the dose administered to subjects in both the cohorts will be different Be it Crossover or parallel study, best way is to use all the volunteers data and add the different dose based on volunteers BSA while calculating the the PK parameters (While doing NCA in Model → Dosing Regimen). Hope this will help! Regards — ~A happy Soul~ |
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kvgreddy06 ☆ India, 2014-04-10 10:48 (4106 d 09:45 ago) @ luvblooms Posting: # 12804 Views: 4,306 |
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Hi All, In case of BABE studies the Inclusion Criteria regarding BMI: EMA and Health Canada guidlines clearly stated that preferably have BMI between 18.5 and 30.0 kg/m². But FDA guidlines doesn't mention any where BMI range, however journals stating that BMI in between 18.5 and 24.5 kg/m². my query is: can we follow as per journals or not?- in asia region studies. or FDA can accept upper limit above 24.5 kg/m². kindly provide your views. Thanks KVGR |
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