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Author: John Blacker
Publisher: Royal Society of Chemistry
ISBN: 1849733074
Category : Science
Languages : en
Pages : 375
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Book Description
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: John Blacker
Publisher: Royal Society of Chemistry
ISBN: 1849733074
Category : Science
Languages : en
Pages : 375
Get Book Here
Book Description
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: Jerry Carr-Brion
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110717913
Category : Technology & Engineering
Languages : en
Pages : 206
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Book Description
Written by an experienced professional, this book introduces chemists to process development, using examples from the pharmaceutical, agrochemical and fragrance industries. The focus is on small molecules rather than biomolecules, and on relatively small-scale production rather than bulk petrochemicals. The coverage is broad, going from initial route development, through pilot plant operations, to full-scale production.
Author: Oljan Repic
Publisher: Wiley-Interscience
ISBN:
Category : Medical
Languages : de
Pages : 248
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Book Description
Dr. Oljan Repic clearly explains the goals and basic principles of chemical development. He explores the crucial aspects of a new process that must be considered when scaling up a research synthesis to industrial levels. And, with the help of many case studies and vignettes, he delineates each phase of the development process. Key topics include qualities of an ideal process, techniques for minimizing impurities, criteria for cost-effective synthesis of enantiopure compounds by resolutions, asymmetric synthesis and the "chiral pool" strategy, synthesis for labeling substances with hydrogen or carbon isotopes, and new drug registration requirements. This book is an invaluable reference for professionals as well as an important source of guidance and inspiration for young chemists considering entering the field.
Author: Derek Walker
Publisher: John Wiley & Sons
ISBN: 0470259507
Category : Medical
Languages : en
Pages : 424
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Book Description
Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on: Directing and carrying out specific tasks and courses of action Making and communicating clear and achievable decisions Solving problems on the spot Managing the administrative aspects of chemical process development The author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into: Understanding the workings of matrix organizations Defining missions and creating action plans Developing interdisciplinary approaches to problem solving Holding review meetings, revising goals, and motivating staff Prioritizing programs and responses to emergencies In addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studies provide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.
Author: Takayuki Shioiri
Publisher: John Wiley & Sons
ISBN: 3527633693
Category : Technology & Engineering
Languages : en
Pages : 544
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Book Description
Covering the whole area of process chemistry in the pharmaceutical industry, this monograph provides the essential knowledge on the basic chemistry needed for future development and key industrial techniques, as well as morphology, engineering and regulatory compliances. Application-oriented and well structured, the authors include recent examples of excellent industrial production of active pharmaceutical ingredients.
Author: Neal G. Anderson
Publisher: Academic Press
ISBN: 0123865387
Category : Science
Languages : en
Pages : 489
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Book Description
Designed to provide a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries, this book describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. It describes hands-on, step-by-step, approaches to solving process development problems, including route, reagent, and solvent selection; optimising catalytic reactions; chiral syntheses; and "green chemistry." Second Edition highlights:• Reflects the current thinking in chemical process R&D for small molecules• Retains similar structure and orientation to the first edition. • Contains approx. 85% new material• Primarily new examples (work-up and prospective considerations for pilot plant and manufacturing scale-up)• Some new/expanded topics (e.g. green chemistry, genotoxins, enzymatic processes)• Replaces the first edition, although the first edition contains useful older examples that readers may refer to - Provides insights into generating rugged, practical, cost-effective processes for the chemical preparation of "small molecules" - Breaks down process optimization into route, reagent and solvent selection, development of reaction conditions, workup, crystallizations and more - Presents guidelines for implementing and troubleshooting processes
Author: Benjamin E. Blass
Publisher: Academic Press
ISBN: 0128172150
Category : Science
Languages : en
Pages : 738
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Book Description
Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator's fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist's early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. - Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property - Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape - Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery - Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry
Author: Steven Ostrove
Publisher: Academic Press
ISBN: 0128096535
Category : Medical
Languages : en
Pages : 219
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Book Description
How to Validate a Pharmaceutical Process provides a "how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the "why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. - Thoroughly referenced and based on the latest research and literature - Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful - Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more
Author: Nozari, Hamed
Publisher: IGI Global
ISBN: 1522559221
Category : Business & Economics
Languages : en
Pages : 399
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Book Description
In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.
Author: Mary T. am Ende
Publisher: John Wiley & Sons
ISBN: 111928550X
Category : Technology & Engineering
Languages : en
Pages : 1435
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Book Description
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.
