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The Management of Chemical Process Development in the Pharmaceutical Industry

The Management of Chemical Process Development in the Pharmaceutical Industry PDF Author: Derek Walker
Publisher: John Wiley & Sons
ISBN: 0470259507
Category : Medical
Languages : en
Pages : 424

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.

The Management of Chemical Process Development in the Pharmaceutical Industry

The Management of Chemical Process Development in the Pharmaceutical Industry PDF Author: Derek Walker
Publisher: John Wiley & Sons
ISBN: 0470259507
Category : Medical
Languages : en
Pages : 424

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.

Pharmaceutical Process Development

Pharmaceutical Process Development PDF Author: John Blacker
Publisher: Royal Society of Chemistry
ISBN: 1849733074
Category : Science
Languages : en
Pages : 374

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.

The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry

The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry PDF Author: Someswara Rao
Publisher: John Wiley & Sons
ISBN: 047031995X
Category : Technology & Engineering
Languages : en
Pages : 1

Book Description
This book brings together the chemical strategies used in the optimisation of organic reactions and processes, and highlights the practical and technological options available. This book offers: an encyclopedic treatment of organic chemistry from an industrial, process research and development, and manufacturing point of view plenty of examples to illustrate the scope and limitation of the strategies a comprehensive index organised by topic, reaction type, and reagent an extensive literature survey. This is an essential and comprehensive guide for experienced practitioners of chemical process research and development, fresh recruits to chemical industry R&D divisions, and academics who are interested in interacting with the chemical industry, optimising their synthetic strategies, and enriching the field of atom economy.

Research and Development Management in the Chemical and Pharmaceutical Industry

Research and Development Management in the Chemical and Pharmaceutical Industry PDF Author: Peter Bamfield
Publisher: John Wiley & Sons
ISBN: 3527606343
Category : Science
Languages : en
Pages : 280

Book Description
Mastering management skills is hard to achieve by newcomers starting their careers in the chemical industry. The message coming from there is that good chemists swiftly have to become good managers if they are to survive and progress in today's competitive climate. This book is designed to help guide younger R & D chemists to ways in which they can quickly evolve skills which are built around three factors - people, knowledge and time. It covers the management of scientific personnel, management within a variety of R & D organisational structures, creating a climate of innovation, the management of projects including the time management and communication aspects of the job. The author, Peter Bamfield, is now working as a consultant. Due to his long experience in the chemical industry, he was elected President of the Royal Society of Chemistry's Industrial Affairs Division. This second edition of the book has been revised and updated to take recent global developments and restructuring in the chemical industry into account, as well as the rising importance of information technology in management.

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry PDF Author: David J. am Ende
Publisher: John Wiley & Sons
ISBN: 1118088107
Category : Technology & Engineering
Languages : en
Pages : 1431

Book Description
This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.

Process Chemistry in the Pharmaceutical Industry, Volume 2

Process Chemistry in the Pharmaceutical Industry, Volume 2 PDF Author: Kumar Gadamasetti
Publisher: CRC Press
ISBN: 9781420008357
Category : Science
Languages : en
Pages : 520

Book Description
As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates. The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends. Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

Pharmaceutical Process Development

Pharmaceutical Process Development PDF Author: A. John Blacker
Publisher: Royal Society of Chemistry
ISBN: 1849731462
Category : Medical
Languages : en
Pages : 375

Book Description
'Pharmaceutical Process Development' is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry and informs them about the breadth of the work carried out in chemical research and development departments.

The Chemistry Of Process Developmet In Fine Chemical & Pharmaceutical Industry 2/Ed

The Chemistry Of Process Developmet In Fine Chemical & Pharmaceutical Industry 2/Ed PDF Author: C. Somerswara Rao
Publisher:
ISBN: 9788186299777
Category : Chemical engineering
Languages : en
Pages : 1311

Book Description
This Book Offers:* An Encyclopedic Treatment Of Organic Chemistry From An Industrial, Process Research And Development, And Manufacturing Point Of View * Plenty Of Examples To Illustrate The Scope And Limitation Of The Strategies* A Comprehensive Index Organised By Topic, Reaction Type, And Reagent And An Extensive Literature Survey.

Handbook for Chemical Process Research and Development

Handbook for Chemical Process Research and Development PDF Author: Wenyi Zhao
Publisher: CRC Press
ISBN: 1315350203
Category : Medical
Languages : en
Pages : 1170

Book Description
The Handbook for Chemical Process Research and Development focuses on developing processes for chemical and pharmaceutical industries. Forty years ago there were few process research and development activities in the pharmaceutical industry, partially due to the simplicity of the drug molecules. However, with the increasing structural complexity, especially the introduction of chiral centers into the drug molecules and strict regulations set by the EMA and FDA, process R&D has become one of the critical departments for pharmaceutical companies. This book assists with the key responsibility of process chemists to develop chemical processes for manufacturing pharmaceutical intermediates and final drug substances for clinical studies and commercial production.

The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry

The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry PDF Author: C. Someswara Rao
Publisher:
ISBN: 9788186299500
Category : Chemical engineering
Languages : en
Pages : 1277

Book Description