Pharmacokinetic Models vs. NCA [Design Issues]

posted by Jaime_R – Barcelona, 2007-02-14 12:44 (7062 d 11:08 ago) – Posting: # 518
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Hi Venu!

❝ In BA/BE studies, why only 2x2 crossover design noncompartmental models are used in most of the pilot and pivotal studies?


Not only 2x2 cross-overs, but also 4x4, 6x3, replicate designs, parallel groups,...

❝ When can you use the compartmental models in the BA/BE stuides?


Additional to NCA you are free to perform any type of evaluation you want. ;-)

❝ Does the use of these compartmental models depend on the nature of the generic drugs.


No.

❝ Please if you could provide more information in detail regarding the questions mentioned above. :-)


For details (especially why compartmental models are not used in BA/BE) see Helmut's post.

Regards, Jaime

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