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1B. Anitha*, 1D. Yashwant Kumar, 1P. Hyma, 2C. Pradeep Kumar
1SARC (Scientific and Applied Research Center) Hyderabad, Telangana, India
2Teegala Krishna Reddy College of Pharmacy, Hyderabad, Telangana, India
A B S T R A C T
Pharmaceutically equivalent multi-source pharmaceutical products must be shown to be therapeutically equivalent to one another in order to be considered interchangeable. From the analyses of pharmacokinetic and statistical results it was inferred that, for the ln-transformed data, the 90 % confidence interval about the test to reference ratio of Cmax, AUC0-t and AUC0-¥ of drug Fesoteridne Fumerate were falling within the bioequivalence acceptance range of 80.00 % – 125.00 %, which demonstrates the bioequivalence of test formulation ‘T’ with reference formulation ‘R’ under fasting conditions. All the study procedures followed were in compliance with the protocol and the ICH-GCP guidelines, Declaration of Helsinki and Schedule Y.
Keywords: Fesoterodine fumarate drug, Bio analytical Process, Pharmacokinetic Analysis, Statistical Analysis
