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 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 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 Technology Transfer written by Mark Gibson and published by . This book was released on 2005 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Technology Transfer Systems in the United States and Germany written by Fraunhofer Institute for Systems and Innovation Research and published by National Academies Press. This book was released on 1997-10-10 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores major similarities and differences in the structure, conduct, and performance of the national technology transfer systems of Germany and the United States. It maps the technology transfer landscape in each country in detail, uses case studies to examine the dynamics of technology transfer in four major technology areas, and identifies areas and opportunities for further mutual learning between the two national systems.
Download or read book Pharmaceutical Technology Transfer written by John Muriithi Mwangi and published by . This book was released on 2019-05-13 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Technology Transfer in Biotechnology written by Prabuddha Ganguli and published by John Wiley & Sons. This book was released on 2009-04-22 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Here, the world's top experts impart their knowledge and experience, many in print for the first time. By considering developing country markets, this book is the first truly global guide to technology transfer, helping companies all around the world to avoid costly mistakes in product development and to recover investments quickly. Individual sections treat trade-related aspects of intellectual property rights, technology transfer in health and healthcare as well as in agriculture and the environment.
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 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 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 Closing the Loop written by Paul F. Witinski and published by . This book was released on 2010 with total page 57 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technology transfer is a significant challenge within the highly regulated pharmaceutical industry. While much focus is put on the logistics and strategy of the process, less attention has been paid to how to change the soft, non-technical aspects of technology transfer program management, even though these cultural, communication, and perception aspects may be just as important for project success. The goal of this study was to provide recommendations on how to change these factors to improve the likelihood of project success for pharmaceutical technology transfers. The work was conducted at Novartis Vaccines and Diagnostics, a large pharmaceutical manufacturer, so the cases studied here were all transfers of complex vaccine processes and products. While the results were intended to be generalizable to intra-firm technology transfers within pharmaceutical companies, some types of possible transfers were not included in this study. The focus of this thesis was on examining different aspects of how companies manage technology transfer projects and correlating these with how successful those projects have been to look for statistically significant relationships. The approach was two-fold: high level surveys and interviews to qualitatively identify commonly seen issues and subsequent effects, followed by a more detailed quantitative survey of individual projects. The results of detailed surveys of individual project found no significant correlations between the studied project management factors and success. Since similar quantitative studies have succeeded in the past, the differences between this study and these previous studies were explored to determine why this particular study did not produce the desired results. Based on the qualitative interview and survey results, the following recommendations were made on how pharmaceutical companies can improve the likelihood of successful technology transfers: 1) increase face-to-face interaction between team members, 2) better align priorities between different functions, sites, and projects, 3) coordinate with corporate senior management to foster collaboration between Research and Technology Development, and 4) fully engage all necessary functions at the start of each project.
Download or read book Containment Technology written by Hans-Jürgen Bässler and published by Springer Science & Business Media. This book was released on 2013-10-01 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers all aspects of containment technology in depth and the latest developments in this exciting field are introduced. This book is a key publication to planning engineers, production managers and those interested in getting a picture of the different applications of the isolator technology. References on literature, laws, norms and guidelines will support the reader to become acquainted with the containment technology.
Download or read book Facets of Technology Transfer written by Manthan D. Janodia and published by . This book was released on 2008 with total page 6 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Process Development written by John Blacker and published by Royal Society of Chemistry. This book was released on 2011-08-17 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.
Download or read book Encyclopedia of Pharmaceutical Technology Self medication to technology transfer considerations for pharmaceuticals written by and published by . This book was released on 1988 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Encyclopedia of Pharmaceutical Technology Supps 1 3 written by and published by . This book was released on 1988 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the discovery development,regulation, manufacturing, and commercialization of drugs and dosage forms. Includes pharmaceuticals,pharmacokinetics, analytical chemistry, quality assurance, toxicology and the manufacturing process.
