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vish14184 ★ India, 2007-12-27 08:01 (6760 d 08:35 ago) Posting: # 1429 Views: 6,813 |
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Dear all, I would like to know that If drug follow non linear pharmacokinetics profile Which type of study design is more suitable for BE study? IF we follow the single dose, cross over, two period study design for non linear pharmacokinetic drug which statistical parameters we should calculate for prove BE? Are there any difference in statistical calculation of AUC0-inf and Kel for non linear pharmacokinetics drugs compare to linear pharmcokinetics drug? for Kel calculation we can use linear least square regression analysis for non linear pharmcokinetic drug? Regards Vishal Nakrani |
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drshiv ★ India, 2008-01-01 08:35 (6755 d 08:01 ago) @ vish14184 Posting: # 1443 Views: 6,139 |
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Hi Vish14184, Your problem is natural. Many people confuse non-linear pharmacokinetics with non-linear regression analysis. Both are different. Non-linear regression also used to calculate pharmacokinetic paramaters for such drugs undergoing NLP. You need to transform the data to some linear form if you wish to calculate Km and Vmax. If not, if you are doing for BE study of single dose, you can folow the methods you use for other drugs. Even these drugs do not exhibit the characteristic PK profile of non-linearity at small or single dose studies (unless you saturate the enzymes). Dr. Shiv |
Ing. Helmut Schütz