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- W2258889981 abstract "Secondary hyperparathyroidism (SHPT) is a majorcomplication of Chronic Kidney Disease (CKD), resulting fromdisturbances in the regulation of PTH, calcium, phosphorus, andvitamin D and Ischemic heart disease (IHD), also called coronaryheart disease or coronary artery disease, is an imbalance betweenmyocardial oxygen demand and supply. A phase-III and Bioequivalencestudy is the mandatory requirement to launch the drug in Indiawhich was not approved in other countries and not in India.newlineA calcimetic drug Cinacalcet for the treatment of SHPT andantianginal drug Ivabradine for the treatment of chronic stableangina were selected for the research work. Method Development wasperformed to develop fast but accurate and precise methods for theestimation of these drug molecules. All the developed methods werevalidated as per the international guidelines of method validation.The application of these validated methods was evaluated on samplesof bioequivalence studies. As efficacy and safety of these drugs inIndian patients was not known. A phase-III studies of these drugswere conducted in Indian patients to evaluate their efficacy andsafety in Indian population. Bioequivalence study shows that boththe drugs are bioequivalent with the reference drug. A clinicalstudy of cinacalcet versus Calcitriol shows that calcimimetic agentcinacalcet provides a novel therapeutic approach for controllingsecondary hyperparathyroidism in patients with chronic kidneydisease in Indian population and A clinical study of Ivabradineversus Atenolol shows that Ivabradine may be an effective and safealternative to the range of options available for the treatment ofstable angina and, potentially, other myocardial ischaemicconditions for Indian population. So Cinacalcet and Ivabradine areeffective and safety for the treatment of SHPT and Chronic stableangina respectively in Indian Patients. newline" @default.
- W2258889981 created "2016-06-24" @default.
- W2258889981 creator A5040502915 @default.
- W2258889981 date "2008-09-27" @default.
- W2258889981 modified "2023-09-23" @default.
- W2258889981 title "A Phase III Clinical and Bioequivalence Study to Evaluate Efficacy and safety of Antihyperparathyroidism and Antianginal drugs in Indian Population" @default.
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