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Author : A. Çilingiroğlu
Publisher :
ISBN 13 :
Total Pages : 122 pages
Book Rating : 4.:/5 (251 download)
Download or read book Transfer of Technology for Pharmaceutical Chemicals written by A. Çilingiroğlu and published by . This book was released on 1975 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ayhan Çilingiroğlu
Publisher : Organisation for Economic Co-operation and Development ; [Washington : sold by OECD Publications Center]
ISBN 13 :
Total Pages : 134 pages
Book Rating : 4.:/5 (31 download)
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:
Author : A. Cilingiro#glu
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (771 download)
Download or read book Transfer of technology for pharmaceutical chemicals written by A. Cilingiro#glu and published by . This book was released on 1975 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ayhan Cilingiroglu
Publisher :
ISBN 13 :
Total Pages : 122 pages
Book Rating : 4.:/5 (76 download)
Download or read book Transfer of technology for pharmaceutical chemicals written by Ayhan Cilingiroglu and published by . This book was released on 1975 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Rajeev M. Pandia
Publisher :
ISBN 13 :
Total Pages : 7 pages
Book Rating : 4.:/5 (864 download)
Download or read book Transfer of Technology : Techniques for Chemical and Pharmaceutical Projects written by Rajeev M. Pandia and published by . This book was released on 1989 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt: In using technology transfer when implementing pharmaceutical projects, project managers can more effectively accomplishing their project's goals and organizations can more successfully compete on a global scale by delivering difficult-to-realize products before these become outdated. Because of this, more companies are demanding that their project managers participate in the technology acquisition process. This article discusses techniques for acquiring the technology needed to implement chemical and pharmaceutical projects. In doing so, it examines the types of technological functions these projects demand, identifying both the quantifiable and the non-quantifiable parameters. It also details approaches for negotiating contracts with vendors; it lists five ways technology affects pharmaceutical projects and 17 sources for locating technology appropriate for the pharmaceutical industry. It then describes approaches for identifying appropriate technology suppliers, bidding for technology, evaluating technologies (in relation to a system's parameters), negotiating use and purchase of technology, and transferring knowledge to use and upgrade technology. Accompanying this article are three appendices: one outlines a bidding process; one lists the major clauses in technology transfer agreements; and one describes the contents of a typical technology package.
Author : Mary T. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 1119285496
Total Pages : 690 pages
Book Rating : 4.1/5 (192 download)
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.
Author : Sanjaya Lall
Publisher : [s.l.] : United Nations
ISBN 13 :
Total Pages : 86 pages
Book Rating : 4.3/5 ( download)
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:
Author : Ajay Babu Pazhayattil
Publisher : Springer
ISBN 13 : 9783031322198
Total Pages : 0 pages
Book Rating : 4.3/5 (221 download)
Download or read book Drug Product Manufacturing Process written by Ajay Babu Pazhayattil and published by Springer. This book was released on 2023-06-22 with total page 0 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.
Author : Mark Gibson
Publisher : CRC Press
ISBN 13 : 1420073184
Total Pages : 562 pages
Book Rating : 4.4/5 (2 download)
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
Author : John Blacker
Publisher : Royal Society of Chemistry
ISBN 13 : 1849733074
Total Pages : 375 pages
Book Rating : 4.8/5 (497 download)
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.
Author : Cornelius Colm O'Mahony
Publisher :
ISBN 13 :
Total Pages : 202 pages
Book Rating : 4.:/5 (264 download)
Download or read book A Project Management Framework for Effective Technology Transfer of New Products, in the Irish Pharmaceutical and Fine Chemical Processing Industry written by Cornelius Colm O'Mahony and published by . This book was released on 2000 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781946964144
Total Pages : 148 pages
Book Rating : 4.9/5 (641 download)
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:
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309487811
Total Pages : 69 pages
Book Rating : 4.3/5 (94 download)
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.
Author : United Nations
Publisher : New York and Geneva : United Nations
ISBN 13 : 9789211126037
Total Pages : 230 pages
Book Rating : 4.1/5 (26 download)
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.
Author : Geoffrey D Tovey
Publisher : Royal Society of Chemistry
ISBN 13 : 1849739412
Total Pages : 432 pages
Book Rating : 4.8/5 (497 download)
Download or read book Pharmaceutical Formulation written by Geoffrey D Tovey and published by Royal Society of Chemistry. This book was released on 2018-06-25 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.
Author : Amit Kumar Nayak
Publisher : Academic Press
ISBN 13 : 0128203005
Total Pages : 572 pages
Book Rating : 4.1/5 (282 download)
Download or read book Advances and Challenges in Pharmaceutical Technology written by Amit Kumar Nayak and published by Academic Press. This book was released on 2021-02-09 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances and Challenges in Pharmaceutical Technology: Materials, Process Development and Drug Delivery Strategies examines recent advancements in pharmaceutical technology. The book discusses common formulation strategies, including the use of tools for statistical formulation optimization, Quality by design (QbD), process analytical technology, and the uses of various pharmaceutical biomaterials, including natural polymers, synthetic polymers, modified natural polymers, bioceramics, and other bioinorganics. In addition, the book covers rapid advancements in the field by providing a thorough understanding of pharmaceutical processes, formulation developments, explorations, and exploitation of various pharmaceutical biomaterials to formulate pharmaceutical dosage forms. Provides extensive information and analysis on recent advancements in the field of pharmaceutical technology Includes contributions from global leaders and experts in academia, industry and regulatory agencies Uses high quality illustrations, flow charts and tables to explain concepts and text to readers, along with practical examples and research case studies
Author : Oliver Schmidt
Publisher : CRC Press
ISBN 13 : 142002602X
Total Pages : 392 pages
Book Rating : 4.4/5 (2 download)
Download or read book Pharmaceutical Quality Systems written by Oliver Schmidt and published by CRC Press. This book was released on 2000-04-30 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr
