International Conference On Harmonization Guidelines

Introduction This protocol is prepared for a human research trial. Based on this document, the trial will be conducted in Canada and on Canadian residents or citizens, according to Good Clinical Practice part of International Conference on Harmonization guidelines (ICH/GCP E6), Health Canada Regulations (Part C, Division 5) applicable government regulations. Metformin is available in Canada as Apo-Metformin but Vildagliptin (Glavus) is not available in Canada and is needed to shipping from US under the Health Canada Regulations (Part C, Division 5). 1.1 Background Diabetes mellitus is a common diseases in the world and Canada is diabetes mellitus. Diabetes Mellitus has been starting to grow all over the world. It is anticipated that the incidence of this disease will be increased dramatically in the next decade. The main reasons of this event are obesity, increasing the population mean age and reducing physical activities especially in industrialized countries. CCDSS has reported that in adult people who are over 20 years old, the prevalence of diabetes mellitus rate was 8.7% (95% CI: 8.72-8.74%), indicating one diabetic patient in 11 healthy Canadians A , B[3, 14]. The common sort of diabetes disease is Diabetes mellitus type 2 (T2DM) that covers the 90% diabetic cases. It is a metabolic disorder that is determined by hyperglycemia (high level of blood sugar) as a result of resistance to insulin in cell membrane and relative lack of insulin [2, 10]. Type 2 diabetes is aShow MoreRelatedInternational Conference On Harmonization Guidelines1802 Words   |  8 Pagestrying a research study on human subjects. Based on this protocol, the trial will be conducted in Canada and on Canadian residents or citizens. All aspects of this study is designed according to Good Clinical Practice part of the International Conference on Harmonization guidelines (ICH/ GCP E6) and Health Canada Regulations (Part C, Division 5) that is mandatory to conduct all the human clinical research in Canada. Metformin is available in Canada as Apo-Metformin but Vildagliptin (Glavus) is not availableRead MoreInternational Conference Of Regulatory Agencies And Industries From Euro pe ( Eu ), Japan, And The United States1377 Words   |  6 Pagesagencies and industries from Europe (EU), Japan, and the United States (US) met together in the International Conference of Harmonization (ICH) and issued guidelines in conducting clinical trials including the of Good Clinical Practice (GCP) guideline. Quality, safety, and efficacy were set as the three basic criteria to approve new medical products which reflect the state-of-the art technology. ICH-GCP guideline was adopted by regulatory agencies of the EU, US, and Japan including the US Food and DrugRead MoreThe International Conference On Harmonization Essay862 Words   |  4 Pagessubcommittees of ICH Streeting Committees The International Conference on Harmonization (ICH) announced on 8 July 2014 that the influential international pharmaceutical regulatory harmonization body has elected to add two new regulators to its Steering Committee from Health Canada (HC) and Swiss regulator. The East African Community (EAC) has joined the International Conference on Harmonization’s (ICH) steering committee as the sixth Regional Harmonization Initiative (RHI) member of the ICH Global CooperationRead MoreEthical Soundness Of Clinical Research1076 Words   |  5 Pagesdefinition of the informed consent process and its importance. In addition, it describes key issues and concerns for obtaining the subjects consent, as well as how this process reflects the code of conduct set forth stated in the International Congress of Harmonization (ICH) Guideline for Good Clinical Practice E6(R1). The Informed Consent Process in Clinical Trials The informed consent process is a multistep process of subject-investigator communication, aims to inform the subjects about theirRead MoreHigh Performance Liquid Chromatographic Method701 Words   |  3 Pagesdeveloped for the determination of buprenorphine hydrochloride in pharmaceutical microemulsion formulation. A forced degradation study of buprenorphine hydrochloride microemulsion formulation was carried out in accordance with International Conference on Harmonization (ICH) guidelines Q1 (R2). The chromatogram was obtained with 10 mmolL−1 potassium phosphate buffer adjusted to pH 6.0 with triethanolamine and acetonitrile (17:83, v/v) as mobile phase, a C-18 column; PrincetonSPHER -100 C18 HPLC column (250Read MoreResearch Related Documents And Data Management1015 Words   |  5 PagesStudents should identify concepts evenly from the subject they have studied in a block and write down as to how these concepts applied or could be used in the learned subject. SCORE OUT OF 10 †¢ Identification of 10 Concepts 1.1. International Conference of Harmonization (ICH) was established to harmonize regulatory regulations This concept originated in the 1990’s to reflect the views of 3 main drug regions (US, Japan and Europe) and their corresponding pharmaceutical organizations to harmonizeRead MoreThe Ethics Of The Clinical Trials1584 Words   |  7 Pagesregulations were established to protect the subjects in the clinical trial after the Tuskegee incident. The Belmont report (1979), International Conference on Harmonization guideline for Good Clinical Practice (1996), the Declaration of Helsinki (2000), and CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) are the main guidelines in recent years. There are also federal regulations to protect human subjects in the clinical trials. They are USCFR Title21 PartRead MoreClinical Trials Are Medically Based Experiments1567 Words   |  7 Pagesconsensus on what constitutes correct conduct and performance of research has been codified on an international level and adopted and modified nationally in the U nited States. Several well-known documents have been developed to outline these principles including: †¢ The Nuremburg Code of 1947 developed in response to the Nuremburg war trials. †¢ The Helsinki Declaration of 1964. †¢ The 1971 Guidelines by the US Department of Health Education and Welfare, codified into formal Federal regulations in 1974Read MoreThe Growth Of Biopharmaceutical Molecules835 Words   |  4 Pagesprimarily attempts to maintain the original quality of the product as it moves throughout the supply chain to different suppliers according to current Good Manufacturing Practices (cGMP), Good Storage Practices (GSP) and GDP.1 The International Conference on Harmonization (ICH) document (ICH Q1A (R2)), states â€Å"a drug product should be evaluated under storage conditions that test the thermal stability and, if applicable, its sensitivity to moisture or potential for solvent loss.†1 The United StatesRead MoreHarmonization of Accounting Standards Through Internationalization5845 Words   |  24 PagesVol. 2, No. 2 International Business Research Harmonization of Accounting Standards through Internationalization Nikhil Chandra Shil, ACMA (Corresponding Author) Department of Business Administration East West University 43, Mohakhali C/A, Dhaka – 1212, Bangladesh Tel: 9887989(Off.) ext 253, 01819289589 (M) Dr. Bhagaban Das P.G. Department of Business Management, Fakir Mohan University P. O.: Balasore, Pin.: 756019, Orissa, India E-mail: bhagaban_fm@yahoo.com Alok Kumar Pramanik Department