The Development And Evaluation Of Januvia Essay - 1202 Words

The development and evaluation of Januvia ® (Sitagliptin Phosphate) are illustrative of the activities that are needed to assess the efficacy, safety and effectiveness of a new product for treating type 2 diabetes milieus. It is the first drug of dipeptidyl peptidase-4 (DPP-4) inhibitors class that is approved as an adjunct to diet and exercise to improve the glycemic control.1 Januvia was developed by Merck Research Laboratories and received the FDA approval on 16 October 2006.2 Preclinical/Animal study: The animal study of MK-0431, the code name for Sitagliptin in early development phase, was done in mice, rat, and dog. Maximum recommended daily adult human dose (MRHD) of Sitagliptin was found 100mg/day and NOAEL 50mg/kg based on dog study.3 Two years of carcinogenic study was conducted on mice and rat. In rat, liver adenoma/carcinoma has been seen at 60 times of MHRD. This is probably due to chronic hepatotoxicity of the drug. No tumor incidence was observed in case of mice up to 70 times of MHRD. Both in vitro assay and in vivo mice assay was not suggestive of mutagenic and clastogenic nature of MK-0431. Fertility adverse effect was also not at 12 times of MHRD)3 and Sitagliptin was labeled as pregnancy category B.4 Based on these preclinical studies on animal, Merck submitted their Investigational New Drug (IND 65, 495) application to FDA was on August 2002.4 Phase I: Phase I of Sitagliptin study was done on 33 volunteer humans. Following 100mg of Sitagliptin oralShow MoreRelatedMba Spring2011 Merck Sample Group Project7196 Words   |  29 PagesInternal Strengths 16 Internal Weakness 20 External Factor Evaluation Matrix 21 Competitive Profile Matrix 23 Internal Factor Evaluation 24 Space Matrix 27 SWOT Matrix 29 Grand Strategy Matrix 31 Recommended Strategies 31 Recommended strategy No.1: 31 Recommended strategy No.2: 32 Projected Financial Statements 33 Projected Ratios 34 Company worth Analysis 34 Annual Objectives: 35 Strategic Review and Evaluation Procedures: 35 Bibliography: 36 Executive Summary: MerckRead MorePublic Awareness of Diabetes2445 Words   |  10 Pagesdiabetes (Centers for Disease Control and Prevention (CDC), 2011). Anyone who is 45 years or older should consider testing for diabetes, especially if he or she is overweight or has a family history of this disease. Race may also play a role in the development of this disease. Individuals who are African American, American Indian, Asian American, Pacific Islander, or Hispanic American/Latino should also consider prescreening (CDC, 2011). Another group of people that are more susceptible to DM2 are lowerRead MoreMerck vs Pfizer7379 Words   |  30 Pagesfuture growth, Merck started focusing on reducing costs, making strategic investments in new product launches, and improving its research and development pipeline. Merck’s sales worldwide reached $48 billion in 2011, which was a 4% increase from 2010. With two drugs under review with the FDA, the company has 19 other drugs in the Phase III of developmen t. b. Pfizer Inc.: History And Background Information Found by Charles Pfizer and Charles Erhart in 1849 Pfizer, Inc. is the largest pharmaceutical