Bioequivalence Requirements In Various Global Jurisdictions PDF Download
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Author | : Isadore Kanfer |
Publisher | : Springer |
Total Pages | : 348 |
Release | : 2017-12-05 |
Genre | : Medical |
ISBN | : 3319680781 |
Download Bioequivalence Requirements in Various Global Jurisdictions Book in PDF, ePub and Kindle
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
Author | : National Academies of Sciences, Engineering, and Medicine |
Publisher | : National Academies Press |
Total Pages | : 169 |
Release | : 2020-04-25 |
Genre | : Medical |
ISBN | : 0309498635 |
Download Regulating Medicines in a Globalized World Book in PDF, ePub and Kindle
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author | : Isadore Kanfer |
Publisher | : CRC Press |
Total Pages | : 334 |
Release | : 2016-04-19 |
Genre | : Medical |
ISBN | : 1420020021 |
Download Generic Drug Product Development Book in PDF, ePub and Kindle
Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica
Author | : |
Publisher | : World Health Organization |
Total Pages | : 70 |
Release | : 2020-09-29 |
Genre | : Business & Economics |
ISBN | : 9240011870 |
Download WHO guideline on country pharmaceutical pricing policies Book in PDF, ePub and Kindle
In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Author | : Lawrence X. Yu |
Publisher | : Springer |
Total Pages | : 472 |
Release | : 2014-09-05 |
Genre | : Medical |
ISBN | : 1493912526 |
Download FDA Bioequivalence Standards Book in PDF, ePub and Kindle
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
Author | : Leon Shargel |
Publisher | : CRC Press |
Total Pages | : 397 |
Release | : 2013-10-24 |
Genre | : Medical |
ISBN | : 1420086367 |
Download Generic Drug Product Development Book in PDF, ePub and Kindle
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
Author | : Ratanawijitrasin S |
Publisher | : World Health Organization |
Total Pages | : 202 |
Release | : 2002-06 |
Genre | : Law |
ISBN | : 9241562064 |
Download Effective Drug Regulation Book in PDF, ePub and Kindle
Seven independent variables were used including the five financing instruments, the firm's ordinary debt, and the firm's operating risk.
Author | : Kung-Chung Liu |
Publisher | : Springer Nature |
Total Pages | : 513 |
Release | : 2019-09-06 |
Genre | : Law |
ISBN | : 981138102X |
Download Innovation, Economic Development, and Intellectual Property in India and China Book in PDF, ePub and Kindle
This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.
Author | : World Intellectual Property Organization |
Publisher | : WIPO |
Total Pages | : 259 |
Release | : 2013 |
Genre | : Law |
ISBN | : 9280523082 |
Download Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade Book in PDF, ePub and Kindle
This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Author | : OECD |
Publisher | : OECD Publishing |
Total Pages | : 219 |
Release | : 2008-09-24 |
Genre | : |
ISBN | : 9264044159 |
Download OECD Health Policy Studies Pharmaceutical Pricing Policies in a Global Market Book in PDF, ePub and Kindle
This report assesses how pharmaceutical pricing and reimbursement policies have contributed to the achievement of certain health policy objectives, and it examines the national and transnational effects of these policies.