Author: Sadao Nagaoka
Publisher: Springer Nature
ISBN: 9811389063
Category : Science
Languages : en
Pages : 338
Book Description
This book analyzes the drug-discovery process in Japan, based on detailed case studies of 12 groups of 15 innovative drugs. It covers the first statin in the world up to the recent major breakthrough in cancer therapy, the recent immune checkpoint inhibitor, the scientific discovery for which a 2018 Nobel Prize in Physiology or Medicine was awarded to Prof. Tasuku Honjo, Kyoto University. The book shows the pervasive high uncertainty in drug discovery: frequent occurrences of unexpected difficulties, discontinuations, serendipities, and good luck, significantly because drug discovery starts when the underlying science is incomplete. Thus, there exist dynamic interactions between scientific progress and drug discovery. High uncertainty also makes the value of an entrepreneurial scientist high. Such scientists fill the knowledge gaps by absorbing external scientific progress and by relentless pursuit of possibilities through their own research, often including unauthorized research, to overcome crises. Further, high uncertainty and its resolution significantly characterize the evolution of competition in the drug industry. The patent system promotes innovation under high uncertainty not only by enhancing appropriability of R&D investment but also by facilitating the combination of knowledge and capabilities among different firms through disclosure. Understanding such a process significantly benefits the creation of innovation management and policy practices.
Drug Discovery in Japan
Author: Sadao Nagaoka
Publisher: Springer Nature
ISBN: 9811389063
Category : Science
Languages : en
Pages : 338
Book Description
This book analyzes the drug-discovery process in Japan, based on detailed case studies of 12 groups of 15 innovative drugs. It covers the first statin in the world up to the recent major breakthrough in cancer therapy, the recent immune checkpoint inhibitor, the scientific discovery for which a 2018 Nobel Prize in Physiology or Medicine was awarded to Prof. Tasuku Honjo, Kyoto University. The book shows the pervasive high uncertainty in drug discovery: frequent occurrences of unexpected difficulties, discontinuations, serendipities, and good luck, significantly because drug discovery starts when the underlying science is incomplete. Thus, there exist dynamic interactions between scientific progress and drug discovery. High uncertainty also makes the value of an entrepreneurial scientist high. Such scientists fill the knowledge gaps by absorbing external scientific progress and by relentless pursuit of possibilities through their own research, often including unauthorized research, to overcome crises. Further, high uncertainty and its resolution significantly characterize the evolution of competition in the drug industry. The patent system promotes innovation under high uncertainty not only by enhancing appropriability of R&D investment but also by facilitating the combination of knowledge and capabilities among different firms through disclosure. Understanding such a process significantly benefits the creation of innovation management and policy practices.
Publisher: Springer Nature
ISBN: 9811389063
Category : Science
Languages : en
Pages : 338
Book Description
This book analyzes the drug-discovery process in Japan, based on detailed case studies of 12 groups of 15 innovative drugs. It covers the first statin in the world up to the recent major breakthrough in cancer therapy, the recent immune checkpoint inhibitor, the scientific discovery for which a 2018 Nobel Prize in Physiology or Medicine was awarded to Prof. Tasuku Honjo, Kyoto University. The book shows the pervasive high uncertainty in drug discovery: frequent occurrences of unexpected difficulties, discontinuations, serendipities, and good luck, significantly because drug discovery starts when the underlying science is incomplete. Thus, there exist dynamic interactions between scientific progress and drug discovery. High uncertainty also makes the value of an entrepreneurial scientist high. Such scientists fill the knowledge gaps by absorbing external scientific progress and by relentless pursuit of possibilities through their own research, often including unauthorized research, to overcome crises. Further, high uncertainty and its resolution significantly characterize the evolution of competition in the drug industry. The patent system promotes innovation under high uncertainty not only by enhancing appropriability of R&D investment but also by facilitating the combination of knowledge and capabilities among different firms through disclosure. Understanding such a process significantly benefits the creation of innovation management and policy practices.
The Changing Economics of Medical Technology
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Drug Discovery
Author: Jie Jack Li
Publisher: John Wiley & Sons
ISBN: 111835446X
Category : Medical
Languages : en
Pages : 572
Book Description
Sets forth the history, state of the science, and future directions of drug discovery Edited by Jie Jack Li and Nobel laureate E. J. Corey, two leading pioneers in drug discovery and medicinal chemistry, this book synthesizes great moments in history, the current state of the science, and future directions of drug discovery into one expertly written and organized work. Exploring all major therapeutic areas, the book introduces readers to all facets and phases of drug discovery, including target selection, biological testing, drug metabolism, and computer-assisted drug design. Drug Discovery features chapters written by an international team of pharmaceutical and medicinal chemists. Contributions are based on a thorough review of the current literature as well as the authors' firsthand laboratory experience in drug discovery. The book begins with the history of drug discovery, describing groundbreaking moments in the field. Next, it covers such topics as: Target identification and validation Drug metabolism and pharmacokinetics Central nervous system drugs In vitro and in vivo assays Cardiovascular drugs Cancer drugs Each chapter features a case study, helping readers understand how science is put into practice throughout all phases of drug discovery. References at the end of each chapter serve as a gateway to groundbreaking original research studies and reviews in the field. Drug Discovery is ideal for newcomers to medicinal chemistry and drug discovery, providing a comprehensive overview of the field. Veterans in the field will also benefit from the perspectives of leading international experts in all aspects of drug discovery.
Publisher: John Wiley & Sons
ISBN: 111835446X
Category : Medical
Languages : en
Pages : 572
Book Description
Sets forth the history, state of the science, and future directions of drug discovery Edited by Jie Jack Li and Nobel laureate E. J. Corey, two leading pioneers in drug discovery and medicinal chemistry, this book synthesizes great moments in history, the current state of the science, and future directions of drug discovery into one expertly written and organized work. Exploring all major therapeutic areas, the book introduces readers to all facets and phases of drug discovery, including target selection, biological testing, drug metabolism, and computer-assisted drug design. Drug Discovery features chapters written by an international team of pharmaceutical and medicinal chemists. Contributions are based on a thorough review of the current literature as well as the authors' firsthand laboratory experience in drug discovery. The book begins with the history of drug discovery, describing groundbreaking moments in the field. Next, it covers such topics as: Target identification and validation Drug metabolism and pharmacokinetics Central nervous system drugs In vitro and in vivo assays Cardiovascular drugs Cancer drugs Each chapter features a case study, helping readers understand how science is put into practice throughout all phases of drug discovery. References at the end of each chapter serve as a gateway to groundbreaking original research studies and reviews in the field. Drug Discovery is ideal for newcomers to medicinal chemistry and drug discovery, providing a comprehensive overview of the field. Veterans in the field will also benefit from the perspectives of leading international experts in all aspects of drug discovery.
A Practical Guide to Drug Development in Academia
Author: Daria Mochly-Rosen
Publisher: Springer Science & Business Media
ISBN: 3319022016
Category : Medical
Languages : en
Pages : 186
Book Description
"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."
Publisher: Springer Science & Business Media
ISBN: 3319022016
Category : Medical
Languages : en
Pages : 186
Book Description
"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."
Natural Products and Drug Discovery
Author: Subhash C. Mandal
Publisher: Elsevier
ISBN: 0081021046
Category : Science
Languages : en
Pages : 778
Book Description
Natural Products and Drug Discovery: An Integrated Approach provides an applied overview of the field, from traditional medicinal targets, to cutting-edge molecular techniques. Natural products have always been of key importance to drug discovery, but as modern techniques and technologies have allowed researchers to identify, isolate, extract and synthesize their active compounds in new ways, they are once again coming to the forefront of drug discovery. Combining the potential of traditional medicine with the refinement of modern chemical technology, the use of natural products as the basis for drugs can help in the development of more environmentally sound, economical, and effective drug discovery processes. Natural Products & Drug Discovery: An Integrated Approach reflects on the current changes in this field, giving context to the current shift and using supportive case studies to highlight the challenges and successes faced by researchers in integrating traditional medicinal sources with modern chemical technologies. It therefore acts as a useful reference to medicinal chemists, phytochemists, biochemists, pharma R&D professionals, and drug discovery students and researchers. - Reviews the changing role of natural products in drug discovery, integrating traditional knowledge with modern molecular technologies - Highlights the potential future role of natural products in preventative medicine - Supported by real world case studies throughout
Publisher: Elsevier
ISBN: 0081021046
Category : Science
Languages : en
Pages : 778
Book Description
Natural Products and Drug Discovery: An Integrated Approach provides an applied overview of the field, from traditional medicinal targets, to cutting-edge molecular techniques. Natural products have always been of key importance to drug discovery, but as modern techniques and technologies have allowed researchers to identify, isolate, extract and synthesize their active compounds in new ways, they are once again coming to the forefront of drug discovery. Combining the potential of traditional medicine with the refinement of modern chemical technology, the use of natural products as the basis for drugs can help in the development of more environmentally sound, economical, and effective drug discovery processes. Natural Products & Drug Discovery: An Integrated Approach reflects on the current changes in this field, giving context to the current shift and using supportive case studies to highlight the challenges and successes faced by researchers in integrating traditional medicinal sources with modern chemical technologies. It therefore acts as a useful reference to medicinal chemists, phytochemists, biochemists, pharma R&D professionals, and drug discovery students and researchers. - Reviews the changing role of natural products in drug discovery, integrating traditional knowledge with modern molecular technologies - Highlights the potential future role of natural products in preventative medicine - Supported by real world case studies throughout
Leading Pharmaceutical Innovation
Author: Oliver Gassmann
Publisher: Springer Science & Business Media
ISBN: 3540247815
Category : Business & Economics
Languages : en
Pages : 184
Book Description
Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies. The authors focus on three sources of pharmaceutical innovation: new management methods, new technologies, and new forms of internationalization. Their findings are illustrated in the case of the Swiss pharmaceutical industry, the leading exporter of pharmaceutical products in percentage of GDP, and some of its main pharmaceutical firms such as Novartis and Hoffmann-La Roche.
Publisher: Springer Science & Business Media
ISBN: 3540247815
Category : Business & Economics
Languages : en
Pages : 184
Book Description
Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies. The authors focus on three sources of pharmaceutical innovation: new management methods, new technologies, and new forms of internationalization. Their findings are illustrated in the case of the Swiss pharmaceutical industry, the leading exporter of pharmaceutical products in percentage of GDP, and some of its main pharmaceutical firms such as Novartis and Hoffmann-La Roche.
Soil, Fertilizer, and Plant Silicon Research in Japan
Author: Jian Feng Ma
Publisher: Elsevier
ISBN: 0080525768
Category : Technology & Engineering
Languages : en
Pages : 294
Book Description
Silicon (Si) plays a significant role in the resistance of plants to multiple stresses including biotic and abiotic stresses. Silicon is also the only element that does not damage plants when accumulated in excess. However, the contribution of Si to plant growth has been largely ignored due to its universal existence in the earth's crust. From numerous intensive studies on Si, initiated in Japan about 80 years ago, Japanese scientists realized that Si was important for the healthy growth of rice and for stability of rice production. In a worldwide first, silicon was recognized as a valuable fertilizer in Japan. The beneficial effects of Si on rice growth in particular, are largely attributable to the characteristics of a silica gel that is accumulated on the epidermal tissues in rice. These effects are expressed most clearly under high-density cultivation systems with heavy applications of nitrogen. Si is therefore recognized now as an ''agronomically essential element'' in Japan.Recently, Si has become globally important because it generates resistance in many plants to diseases and pests, and may contribute to reduced rates of application of pesticides and fungicides. Silicon is also now considered as an environment-friendly element. The achievements of Si research in Japan are introduced in this book, in relation to soils, fertilizers and plant nutrition.
Publisher: Elsevier
ISBN: 0080525768
Category : Technology & Engineering
Languages : en
Pages : 294
Book Description
Silicon (Si) plays a significant role in the resistance of plants to multiple stresses including biotic and abiotic stresses. Silicon is also the only element that does not damage plants when accumulated in excess. However, the contribution of Si to plant growth has been largely ignored due to its universal existence in the earth's crust. From numerous intensive studies on Si, initiated in Japan about 80 years ago, Japanese scientists realized that Si was important for the healthy growth of rice and for stability of rice production. In a worldwide first, silicon was recognized as a valuable fertilizer in Japan. The beneficial effects of Si on rice growth in particular, are largely attributable to the characteristics of a silica gel that is accumulated on the epidermal tissues in rice. These effects are expressed most clearly under high-density cultivation systems with heavy applications of nitrogen. Si is therefore recognized now as an ''agronomically essential element'' in Japan.Recently, Si has become globally important because it generates resistance in many plants to diseases and pests, and may contribute to reduced rates of application of pesticides and fungicides. Silicon is also now considered as an environment-friendly element. The achievements of Si research in Japan are introduced in this book, in relation to soils, fertilizers and plant nutrition.
Antibody Drug Discovery
Author: Clive R. Wood
Publisher: World Scientific
ISBN: 1848166281
Category : Medical
Languages : en
Pages : 490
Book Description
Antibody-based therapeutics are a central driver of the success of biopharmaceuticals. The discovery technology of this field is isolated to a limited number of centers of excellence in industry and academia. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field. Each chapter is written with a historical perspective that sets into context the significance of the key developments, and with the provision of “points to consider” for the reader as a value-added feature of the volume. All contributors are experts in their fields and have played pivotal roles in the creation of the technology.
Publisher: World Scientific
ISBN: 1848166281
Category : Medical
Languages : en
Pages : 490
Book Description
Antibody-based therapeutics are a central driver of the success of biopharmaceuticals. The discovery technology of this field is isolated to a limited number of centers of excellence in industry and academia. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field. Each chapter is written with a historical perspective that sets into context the significance of the key developments, and with the provision of “points to consider” for the reader as a value-added feature of the volume. All contributors are experts in their fields and have played pivotal roles in the creation of the technology.
Carbohydrate-based Drug Discovery, 2 Volume Set
Author: Chi-Huey Wong
Publisher: John Wiley & Sons
ISBN: 9783527306329
Category : Science
Languages : de
Pages : 520
Book Description
Die Suche nach Medikamenten mit neuen oder verbesserten Eigenschaften hat das Interesse am pharmazeutischen Potenzial von Kohlenhydraten enorm verstärkt. Dies gilt insbesondere für die Entwicklung von Antibiotika, Impfstoffen und Anti-Krebs-Mitteln. Carbohydrate-based Drug Discovery stellt mit mehr als 50 Beiträgen der weltweit führenden Experten die neuesten Entwicklungen in der Kohlenhydrat- und Biochemie vor. Dabei liegt der Schwerpunkt der Darstellung auf der pharmazeutischen Anwendung. In jüngster Zeit sind wirksame, auf Kohlenhydraten basierende Medikamente gegen HIV, Grippe, Epilepsie, Diabetes und Krebs auf den Markt gekommen bzw. werden in Studien klinisch erprobt. Doch das gesamte Potenzial dieser Substanzklasse kann man bislang wohl nur erahnen. Die pharmazeutische Industrie investiert bereits große Summen in die Forschung und Entwicklung. So kommt dieses Handbuch genau zur richtigen Zeit. Umfassend und kompetent behandelt es den gesamten Bereich der Kohlenhydratchemie. Es führt ein in die chemische Synthese, in Biosynthese und Metabolismus und informiert über die Analyse und die zellulären Funktionen von Kohlenhydraten. Einen weiteren Schwerpunkt bildet die Entwicklung von Medikamenten auf Kohlenhydrat-Basis, wie z.B. synthetischer Impfstoffe oder Thrombosemittel auf Basis synthetischer Oligosaccharide. Erschlossen wird das mit einem umfangreichen bibliographischen Anhang versehene Werk durch einen thematischen Index. Sein Herausgeber, Chi-Huey Wong, hat bereits mehrere internationale Preise für sein wissenschaftliches Werk erhalten, darunter den "Presidential Award" und den "Presidential Young Investigator Award".
Publisher: John Wiley & Sons
ISBN: 9783527306329
Category : Science
Languages : de
Pages : 520
Book Description
Die Suche nach Medikamenten mit neuen oder verbesserten Eigenschaften hat das Interesse am pharmazeutischen Potenzial von Kohlenhydraten enorm verstärkt. Dies gilt insbesondere für die Entwicklung von Antibiotika, Impfstoffen und Anti-Krebs-Mitteln. Carbohydrate-based Drug Discovery stellt mit mehr als 50 Beiträgen der weltweit führenden Experten die neuesten Entwicklungen in der Kohlenhydrat- und Biochemie vor. Dabei liegt der Schwerpunkt der Darstellung auf der pharmazeutischen Anwendung. In jüngster Zeit sind wirksame, auf Kohlenhydraten basierende Medikamente gegen HIV, Grippe, Epilepsie, Diabetes und Krebs auf den Markt gekommen bzw. werden in Studien klinisch erprobt. Doch das gesamte Potenzial dieser Substanzklasse kann man bislang wohl nur erahnen. Die pharmazeutische Industrie investiert bereits große Summen in die Forschung und Entwicklung. So kommt dieses Handbuch genau zur richtigen Zeit. Umfassend und kompetent behandelt es den gesamten Bereich der Kohlenhydratchemie. Es führt ein in die chemische Synthese, in Biosynthese und Metabolismus und informiert über die Analyse und die zellulären Funktionen von Kohlenhydraten. Einen weiteren Schwerpunkt bildet die Entwicklung von Medikamenten auf Kohlenhydrat-Basis, wie z.B. synthetischer Impfstoffe oder Thrombosemittel auf Basis synthetischer Oligosaccharide. Erschlossen wird das mit einem umfangreichen bibliographischen Anhang versehene Werk durch einen thematischen Index. Sein Herausgeber, Chi-Huey Wong, hat bereits mehrere internationale Preise für sein wissenschaftliches Werk erhalten, darunter den "Presidential Award" und den "Presidential Young Investigator Award".
Drugs
Author: Rick Ng
Publisher: John Wiley & Sons
ISBN: 1118210700
Category : Science
Languages : en
Pages : 368
Book Description
"Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs." —Doody's Reviews, May 2009 "The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials." —Chemistry World, February 2009 The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter. Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.
Publisher: John Wiley & Sons
ISBN: 1118210700
Category : Science
Languages : en
Pages : 368
Book Description
"Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs." —Doody's Reviews, May 2009 "The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials." —Chemistry World, February 2009 The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter. Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.