1.1 Definition of medicine terminology Medication, drug, pharmaceutical drug and medicine are a set of terms symbolize to a single meaning, which have many definitions from different sources. Definitions of pharmaceutical quality have been evolving for years. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has defined drug quality, simply, as “the ability of a product to satisfy stated needs
Federation of pharmaceutical industries and Associations (EFPIA) • Ministry of Health, Labour and Welfare (JAPAN) • Japan Pharmaceutical Manufacturers Association(JPMA) • Food and Drug administration(FDA) • Pharmaceutical and Research and Manufacturers of America(PhRMA) The ICH Global Cooperation Group (GCG) and the ICH MedDRA management Board are subcommittees of ICH Streeting Committees The International Conference on Harmonization (ICH) announced on 8 July 2014 that the influential international pharmaceutical
8 CLINICAL TRIALS 8.1 INTRODUCTION Clinical trials are medically based experiments undertaken on human subjects to systematically determine the effectiveness and/or safety of therapeutic interventions. Formal definitions of clinical trials are numerous, but they capture the concept of an organized, systematic study of human subjects in a treatment environment that is consistent.245 Studies are created to measure different things, such as determining whether a treatment is effective compared to a
tests to prove its medicinal ability is sufficient for the medicines market. Preclinical Development Preclinical testing performed by graduate researchers (Ph.D level), evaluate the medicines safety and efficacy before the medicine can be tested on humans. The medicine is rigorously tested for a 3-6 year period to assess its safety, biological activity, therapeutic ratio, and side effects in laboratory (in vitro) and on animals (in vivo). In vitro testing the drug is tested on cell cultures and
In order for biotechnology and pharmaceutical companies to market their biologics and drugs, companies must receive approval from their respective regulatory authority. The three global leaders in the pharmaceutical industry US, EU, and Japan all have their own regulatory authorities. Each have their advantages and disadvantages and as a regulatory representative. Though there is a push to harmonize regulatory requirements at a global scale for the past 20 years development and approval of global
Pharmaceutical analysis: It is the interdisciplinary subject and it is derived from various branches of sciences like chemistry,physics, microbiology, nuclear science and electronics which deals with analysis of biological, chemicals, foods, drugs and pharmaceuticals qualitatively and quantitatively. Pharmaceutical Analytical Techniques are categorized into: Pharmaceutical Analytical Techniques
Pharmaceutical Price Controls in OECD Countries Implications for U.S. Consumers, Pricing, Research and Development, and Innovation U.S. Department of Commerce International Trade Administration The International Trade Administration (ITA) has as its mission the creation of economic opportunity for U.S. workers and firms by promoting international trade, opening foreign markets, ensuring compliance with trade laws and agreements, and supporting U.S. commercial interests at home and abroad
fulfillment of the requirements for the degree of MASTER OF BUSINESS ADMINISTRATION A Dissertation entitled The effects of an AOR (action-observation-reflection) based Supplier Monitoring Program on the Quality of Strategic Supplier Performance. By Carlo Giovanni Conti We hereby certify that this Dissertation submitted by Carlo Giovanni Conti conforms to acceptable standards, and as such is fully adequate in scope and quality.
Plagiarism Bibliography Buckwalter, J. A., Wright, T., Mogoanta, L. and Alman, B. (2012), Plagiarism: An assault on the integrity of scientific research. J. Orthop. Res., 30: 1867 1868. Granitz, N. and Loewy, D. (2007). Applying Ethical Theories: Interpreting and Responding to Student Plagiarism. Journal of Business Ethics, 72(3), 293-306. Luke, B. and Kearins, K. (2012), Attribution of words versus attribution of responsibilities: Academic plagiarism and university practice. Vaccine, 30(50):
FCNA Prof. A. A. Okwoli, Ph.D, FCNA Prof. Abimaje Akpa, Ph.D, FCNA Prof. B. C. Osisioma, Ph.D, FCNA Prof. Edet B. Akpakpan, Ph.D, FCNA, Prof. A. C. Ezejulue, Ph.D, FCNA Prof. A. S. Mikailu, Ph.D, FNIA Chairman, Education, Training, Research and Technical Committee, ANAN Chief V. C. Azie Accountant-General of the Federation Auditor-General of the Federation Registrar, ANAN Chairman, Fed. Inland Revenue Service Director of Research, National Universities Commission Treasurer,