Download or read book Pharmaceutical Production and Related Technology Transfer written by World Health Organization and published by . This book was released on 2011 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Technology Transfer written by Ajay Babu Pazhayattil and published by Springer Nature. This book was released on 2023-06-16 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements of the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook’s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.
Download or read book Transfer of Technology for Pharmaceutical Chemicals written by Ayhan Çilingiroğlu and published by Organisation for Economic Co-operation and Development ; [Washington : sold by OECD Publications Center]. This book was released on 1975 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-01-24 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Preformulation and Formulation written by Mark Gibson and published by CRC Press. This book was released on 2016-04-19 with total page 562 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne
Download or read book Transfer of Technology for Successful Integration Into the Global Economy written by United Nations and published by New York and Geneva : United Nations. This book was released on 2003 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication contains three case studies which seek to disseminate information on best practices for promoting transfer of technology in developing countries, in order to help establish new industries which can successfully compete in the global economy. These studies were carried out under the UNCTAD/UNDP Programme on Globalization, Liberalization and Sustainable Human Development, and deal with aircraft manufacturing in Brazil, the pharmaceuticals sector in India and the automobile industry in South Africa.
Download or read book Major Issues in Transfer of Technology to Developing Countries written by Sanjaya Lall and published by [s.l.] : United Nations. This book was released on 1975 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Technology Transfer in the Pharmaceutical Industry written by Lawrence H. Wortzel and published by . This book was released on 1971 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Intellectual Property Pharmaceuticals and Public Health written by Kenneth C. Shadlen and published by Edward Elgar Publishing. This book was released on 2011-01-01 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'This impressive collection offers fascinating new perspectives on the impact of pharmaceutical patents on access to medicines in developing countries. The volume's editors have put together an important book that sets out clearly the challenges to public health in a wide range of national contexts. The book will be a valuable text for all scholars and decision-makers interested in the global politics of intellectual property rights and public health.' – Duncan Matthews, Queen Mary, University of London, UK This up-to-date book examines pharmaceutical development, access to medicines, and the protection of public health in the context of two fundamental changes that the global political economy has undergone since the 1970s, the globalization of trade and production and the increased harmonization of national regulations on intellectual property rights. With authors from eleven different countries presenting case studies of national experiences in Africa, Asia and the Americas, the book analyzes national strategies to promote pharmaceutical innovation, while at the same time assuring widespread access to medicines through generic pharmaceutical production and generic pharmaceutical importation. The expert chapters focus on patents as well as an array of regulatory instruments, including pricing and drug registration policies. Presenting in-depth analysis and original empirical research, this book will strongly appeal to academics and students of intellectual property, international health, international political economy, international development and law.
Download or read book Technology Transfer written by and published by . This book was released on 1988 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Technology Transfer written by Abhishek Pandey and published by LAP Lambert Academic Publishing. This book was released on 2012-02 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful Technology transfer enables the production of new dosage form so it is important to remove the barriers to the free flow of technology as well as to the free flow of science. This book addresses the various concepts and recommendations on the activities necessary to conduct a successful transfer of technology guidelines. The intention is to describe the basic considerations needed for successful transfer in order to satisfy the regulatory authority. It imparts the knowledge of various issues like steps involved in technology transfer, documentation needed, effective and failure factors, intellectual property rights on technology transfer, Role of R & D manager, it also emphasized on the policies which are needed to be rebuild to promote the effective technology transfer from R&D to production level.Ultimate goal of this book is to provide insight depth to pharmacy research scholar on various key concepts of Pharmaceutical Technology Transfer in order to carve their technical skills
Download or read book Vaccines Medicines and COVID 19 written by Germán Velásquez and published by Springer Nature. This book was released on 2022-01-01 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. Many of these countries and nations wanted to explore COVID-19 on their own, sometimes without listening to the main international health bodies such as WHO, an agency of the United Nations system with long-standing experience and vast knowledge at the global level and of which all countries in the world are members. In this single volume, the chapters present the progress of thinking and debate — particularly in relation to drugs and vaccines — that would enable a response to the COVID-19 pandemic or to subsequent crises that may arise. Among the topics covered: COVID-19 Vaccines: Between Ethics, Health and Economics Medicines and Intellectual Property: 10 Years of the WHO Global Strategy Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock Intellectual Property and Access to Medicines and Vaccines The World Health Organization Reforms in the Time of COVID-19 Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice? is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO); World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) staff participating in these negotiations; academics and students of public health, medicine, health sciences, law, sociology and political science; and intergovernmental organizations and non-governmental organizations that follow the issue of access to treatments and vaccines for COVID-19.
Download or read book Technology Transfer in the Pharmaceutical Industry written by and published by . This book was released on 1972 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Industrial pharmacy written by B NAGARANI and published by Blue Rose Publishers. This book was released on 2021-08-23 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this book is to introduce Pharmacy students to fundamentals of principles, practices and technologies involved in product development and also about Regulatory affairs.An excellent presentation is used in this book to demonstrate the interrelationship between laboratory scaling of pharmaceutical products, pilot plants and regulatory affairs. An extensive overview of various regulatory bodies, their guidelines and regulations governing the manufacturing and compounding of Pharmaceuticals are also explained.The present text book is made completely as per PCI syllabus to make an easy understanding for the students. Each chapter of this book is written at a level of students requirements. The objective upon completion of subject student can be able to 1. Know the process of Technology transfer from lab scale to commercial scale. 2. Know the process of pilot plant scale up of Pharmaceutical dosage form. 3. Know the various regulatory guidelines for pharmaceutical Industry. 4. Understand the approval process and regulatory requirements for drug product.
Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-09 with total page 690 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
Download or read book Organizing Global Technology Flows written by Pierre-Yves Donzé and published by Routledge. This book was released on 2013-11-12 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research on the international transfer of technology in economics and management literature has primarily focused on the role of countries and that of companies, in particular multinational enterprises (MNEs). Similarly, economic and business historians have tended to view international technology transfer as a way for economically ‘backward’ countries to acquire new technologies in order to catch up with more developed economies. This volume provides a more in-depth understanding of how the international transfer of technologies is organized and, in particular, challenges the core-periphery model that is still dominant in the extant literature. By looking beyond national systems of innovation, and statistics on foreign trade, patent registration and foreign direct investment, the book sheds more light on the variety of actors involved in the transfer process (including engineers, entrepreneurs, governments, public bodies, firms, etc.) and on how they make use of a broad set of national and international institutions facilitating technology transfer. Put differently, the volume offers a better understanding of the complexity of global technology flows by examining the role and actions of the different actors involved. By bringing together a number of original case studies covering many different countries over the period from the late 19th to the 21st century, the book demonstrates how technology is being transferred through complex processes, involving a variety of actors from several countries using the national and international institutional frameworks.
