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Scholars Journal of Applied Medical Sciences | Volume-1 | Issue-03
Evaluation of Hematology and Biochemistry at Baseline and at End of study in Normal Healthy Post Menopausal Women administered with Combined Progesterone and Estradiol capsules in Bioequivalence studies
Ganesan M, Ashok P, Ragunath M P, Elangovan N, Venkatarao K, Sailakshmi L, Methavi, Kathiravan S, Sudha A, Gopinath A, Kandida S, Sharmila S, Vasugidevi A
Published: June 30, 2013 |
106
64
DOI: 10.36347/sjams.2013.v01i03.007
Pages: 172-176
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Abstract
Abstract: Current practices of bioequivalence studies perform safety assessment by visibly comparing screening and post study laboratory values. Safety assessment (hematology and biochemical parameters) not actually compared for generic drug with brand drug. Our objective is to establish a statistical method to compare and evaluate blood hematology and biochemistry parameters at baseline and at end of the study. In this research analysis, the safety of the combined progesterone and estradiol capsules evaluated in three cross over design, normal and healthy post menopausal women bioequivalence studies conducted by the Contract research organization, Micro Therapeutic Research Labs Pvt Ltd.