Author: Michael R. Kilbourn
Publisher: John Wiley & Sons
ISBN: 1119500540
Category : Science
Languages : de
Pages : 768
Book Description
Sorgfältig aktualisierte Neuauflage dieses wegweisenden Referenzwerk der radiopharmazeutischen Wissenschaften Die 2. Auflage des Handbook of Radiopharmaceuticals wirft einen umfassenden analytischen Blick auf das Fachgebiet und bietet aktuelle Informationen zu zentralen Themen, u. a. die Herstellung von Radionukliden, synthetische Methoden, Entwicklungen in der Radiopharmazie, Regelwerke, und zu einer Fülle praktischer Anwendungen. Als wertvolles Nachschlagewerk für Einsteiger und erfahrene Praktiker untersucht diese Publikation die neuesten Konzepte und Fragestellungen unter Berücksichtigung des gezielten Einsatzes diagnostischer und therapeutischer Radiopharmazeutika. Die Beiträge stammen von Experten verschiedenster Unterdisziplinen und lassen den Leser eintauchen in die Radiochemie, Nuklearmedizin, molekulare Bildgebung u.v.m. Die Nuklearmedizin und radiopharmazeutischen Wissenschaften haben sich seit Veröffentlichung der 1. Auflage stark verändert. Neue Radiopharmazeutika für Diagnostik und Therapie wurden von der FDA zugelassen, klinische PET- und SPECT-Scans haben drastisch zugenommen und Fortschritte im Bereich Künstliche Intelligenz haben zu signifikant verbesserten Forschungsverfahren geführt. Diese vollständig überarbeitete Auflage stellt den derzeitigen Erkenntnisstand des Fachgebiets vor, ergänzt um aktualisierte und neue Inhalte. Neue Kapitel beschäftigen sich mit heutigen Good Manufacturing Practice, regulatorischen Entwicklungen und neuen Ansätzen bei der Qualitätskontrolle. Damit wird sichergestellt, dass die Leserschaft über die aufregenden Entwicklungen der letzten Jahre rundum im Bilde ist. Dieses wichtige Referenzwerk - bietet durchgängig neue und überarbeitete Inhalte. - deckt zentrale Anwendungsbereiche in der Diagnostik und Therapie ab, für die Onkologie, Neurologie und Kardiologie. - unterstreicht die multidisziplinäre Ausrichtung der radiopharmazeutischen Wissenschaften. - zeigt, wie Pharmaunternehmen mit modernen Bildgebungsverfahren der Radiopharmazie neue Medikamente entwickeln. - untersucht heutige und neue Anwendungen der Positronen-Emissions-Tomographie (PET) und Single-Photonen-Emissions-Computertomographie (SPECT). Die Herausgeber sind anerkannte Experten der Fachrichtungen Radiochemie und PET-Bildgebung. Die 2. Auflage des Handbook of Radiopharmaceuticals: Radiochemistry and Applications ist ein Muss für Postdoktoranden, Forscher und Fachexperten in der Pharmazeutischen Industrie und richtet sich ebenso an die akademische Forschung und Lehre, an Graduierte und Einsteiger in das Fachgebiet der Radiopharmazeutika.
Handbook of Radiopharmaceuticals
Author: Michael R. Kilbourn
Publisher: John Wiley & Sons
ISBN: 1119500540
Category : Science
Languages : de
Pages : 768
Book Description
Sorgfältig aktualisierte Neuauflage dieses wegweisenden Referenzwerk der radiopharmazeutischen Wissenschaften Die 2. Auflage des Handbook of Radiopharmaceuticals wirft einen umfassenden analytischen Blick auf das Fachgebiet und bietet aktuelle Informationen zu zentralen Themen, u. a. die Herstellung von Radionukliden, synthetische Methoden, Entwicklungen in der Radiopharmazie, Regelwerke, und zu einer Fülle praktischer Anwendungen. Als wertvolles Nachschlagewerk für Einsteiger und erfahrene Praktiker untersucht diese Publikation die neuesten Konzepte und Fragestellungen unter Berücksichtigung des gezielten Einsatzes diagnostischer und therapeutischer Radiopharmazeutika. Die Beiträge stammen von Experten verschiedenster Unterdisziplinen und lassen den Leser eintauchen in die Radiochemie, Nuklearmedizin, molekulare Bildgebung u.v.m. Die Nuklearmedizin und radiopharmazeutischen Wissenschaften haben sich seit Veröffentlichung der 1. Auflage stark verändert. Neue Radiopharmazeutika für Diagnostik und Therapie wurden von der FDA zugelassen, klinische PET- und SPECT-Scans haben drastisch zugenommen und Fortschritte im Bereich Künstliche Intelligenz haben zu signifikant verbesserten Forschungsverfahren geführt. Diese vollständig überarbeitete Auflage stellt den derzeitigen Erkenntnisstand des Fachgebiets vor, ergänzt um aktualisierte und neue Inhalte. Neue Kapitel beschäftigen sich mit heutigen Good Manufacturing Practice, regulatorischen Entwicklungen und neuen Ansätzen bei der Qualitätskontrolle. Damit wird sichergestellt, dass die Leserschaft über die aufregenden Entwicklungen der letzten Jahre rundum im Bilde ist. Dieses wichtige Referenzwerk - bietet durchgängig neue und überarbeitete Inhalte. - deckt zentrale Anwendungsbereiche in der Diagnostik und Therapie ab, für die Onkologie, Neurologie und Kardiologie. - unterstreicht die multidisziplinäre Ausrichtung der radiopharmazeutischen Wissenschaften. - zeigt, wie Pharmaunternehmen mit modernen Bildgebungsverfahren der Radiopharmazie neue Medikamente entwickeln. - untersucht heutige und neue Anwendungen der Positronen-Emissions-Tomographie (PET) und Single-Photonen-Emissions-Computertomographie (SPECT). Die Herausgeber sind anerkannte Experten der Fachrichtungen Radiochemie und PET-Bildgebung. Die 2. Auflage des Handbook of Radiopharmaceuticals: Radiochemistry and Applications ist ein Muss für Postdoktoranden, Forscher und Fachexperten in der Pharmazeutischen Industrie und richtet sich ebenso an die akademische Forschung und Lehre, an Graduierte und Einsteiger in das Fachgebiet der Radiopharmazeutika.
Publisher: John Wiley & Sons
ISBN: 1119500540
Category : Science
Languages : de
Pages : 768
Book Description
Sorgfältig aktualisierte Neuauflage dieses wegweisenden Referenzwerk der radiopharmazeutischen Wissenschaften Die 2. Auflage des Handbook of Radiopharmaceuticals wirft einen umfassenden analytischen Blick auf das Fachgebiet und bietet aktuelle Informationen zu zentralen Themen, u. a. die Herstellung von Radionukliden, synthetische Methoden, Entwicklungen in der Radiopharmazie, Regelwerke, und zu einer Fülle praktischer Anwendungen. Als wertvolles Nachschlagewerk für Einsteiger und erfahrene Praktiker untersucht diese Publikation die neuesten Konzepte und Fragestellungen unter Berücksichtigung des gezielten Einsatzes diagnostischer und therapeutischer Radiopharmazeutika. Die Beiträge stammen von Experten verschiedenster Unterdisziplinen und lassen den Leser eintauchen in die Radiochemie, Nuklearmedizin, molekulare Bildgebung u.v.m. Die Nuklearmedizin und radiopharmazeutischen Wissenschaften haben sich seit Veröffentlichung der 1. Auflage stark verändert. Neue Radiopharmazeutika für Diagnostik und Therapie wurden von der FDA zugelassen, klinische PET- und SPECT-Scans haben drastisch zugenommen und Fortschritte im Bereich Künstliche Intelligenz haben zu signifikant verbesserten Forschungsverfahren geführt. Diese vollständig überarbeitete Auflage stellt den derzeitigen Erkenntnisstand des Fachgebiets vor, ergänzt um aktualisierte und neue Inhalte. Neue Kapitel beschäftigen sich mit heutigen Good Manufacturing Practice, regulatorischen Entwicklungen und neuen Ansätzen bei der Qualitätskontrolle. Damit wird sichergestellt, dass die Leserschaft über die aufregenden Entwicklungen der letzten Jahre rundum im Bilde ist. Dieses wichtige Referenzwerk - bietet durchgängig neue und überarbeitete Inhalte. - deckt zentrale Anwendungsbereiche in der Diagnostik und Therapie ab, für die Onkologie, Neurologie und Kardiologie. - unterstreicht die multidisziplinäre Ausrichtung der radiopharmazeutischen Wissenschaften. - zeigt, wie Pharmaunternehmen mit modernen Bildgebungsverfahren der Radiopharmazie neue Medikamente entwickeln. - untersucht heutige und neue Anwendungen der Positronen-Emissions-Tomographie (PET) und Single-Photonen-Emissions-Computertomographie (SPECT). Die Herausgeber sind anerkannte Experten der Fachrichtungen Radiochemie und PET-Bildgebung. Die 2. Auflage des Handbook of Radiopharmaceuticals: Radiochemistry and Applications ist ein Muss für Postdoktoranden, Forscher und Fachexperten in der Pharmazeutischen Industrie und richtet sich ebenso an die akademische Forschung und Lehre, an Graduierte und Einsteiger in das Fachgebiet der Radiopharmazeutika.
Trends On The Role Of Pet In Drug Development
Author: Philip H Elsinga
Publisher: World Scientific
ISBN: 9814464317
Category : Medical
Languages : en
Pages : 799
Book Description
Drug development is very expensive and a fight against time. PET offers possibilities to speed up this process by adding unique in vivo information on pharmacokinetics/dynamics of a drug at an early stage. This information can help decision makers to move the drug in the drug development process or to decide to stop further developments. This unique and complete book highlights the different ways PET can be used and describes the latest trends in the various disciplines within nuclear medicine to further improve methodologies and increase the number of tools to accelerate drug development. Various topics within tracer development, instrumentation, data analysis and many clinical and preclinical topics are described by leading scientists from industry and academia.
Publisher: World Scientific
ISBN: 9814464317
Category : Medical
Languages : en
Pages : 799
Book Description
Drug development is very expensive and a fight against time. PET offers possibilities to speed up this process by adding unique in vivo information on pharmacokinetics/dynamics of a drug at an early stage. This information can help decision makers to move the drug in the drug development process or to decide to stop further developments. This unique and complete book highlights the different ways PET can be used and describes the latest trends in the various disciplines within nuclear medicine to further improve methodologies and increase the number of tools to accelerate drug development. Various topics within tracer development, instrumentation, data analysis and many clinical and preclinical topics are described by leading scientists from industry and academia.
The Use of Drugs in Food Animals
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309175771
Category : Medical
Languages : en
Pages : 276
Book Description
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
Publisher: National Academies Press
ISBN: 0309175771
Category : Medical
Languages : en
Pages : 276
Book Description
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
Drug Efflux Pumps in Cancer Resistance Pathways: From Molecular Recognition and Characterization to Possible Inhibition Strategies in Chemotherapy
Author:
Publisher: Academic Press
ISBN: 0128141417
Category : Medical
Languages : en
Pages : 396
Book Description
Drug Efflux Pumps in Cancer Resistance Pathways: From Molecular Recognition and Characterization to Possible Inhibition Strategies in Chemotherapy, Volume Seven, describes the fundamental aspects of efflux pumps of the ATP-binding cassette superfamily in cancer resistance pathways, along with strategies to target and improve chemotherapy efficacy. Pumps of the ATP-binding cassette superfamily (ABCs) regulate the access of drugs to the intracellular space. In this context, the overexpression of ABCs is a well-known mechanism of multidrug resistance in cancer and is associated with therapeutic failure. Cancer types discussed include breast, endocrine, hematologic, gastrointestinal, musculoskeletal, lung, skin and central nervous system cancers. The book is a valuable source for researchers and advanced students in cancer, biology, pharmacology, pharmaceutical sciences, biomaterials and medical/clinical sciences that are interested in accessing a comprehensive compendium on efflux pumps in mechanisms of cancer resistance. - Offers comprehensive and detailed descriptions of the basic aspects of efflux pumps in a very schematic and didactic manner - Describes the involvement of efflux pumps in cancer resistance in different cancer types - Encompasses an updated overview on state-of-the-art approaches that capitalize on their inhibition to improve chemotherapy and overcome resistance
Publisher: Academic Press
ISBN: 0128141417
Category : Medical
Languages : en
Pages : 396
Book Description
Drug Efflux Pumps in Cancer Resistance Pathways: From Molecular Recognition and Characterization to Possible Inhibition Strategies in Chemotherapy, Volume Seven, describes the fundamental aspects of efflux pumps of the ATP-binding cassette superfamily in cancer resistance pathways, along with strategies to target and improve chemotherapy efficacy. Pumps of the ATP-binding cassette superfamily (ABCs) regulate the access of drugs to the intracellular space. In this context, the overexpression of ABCs is a well-known mechanism of multidrug resistance in cancer and is associated with therapeutic failure. Cancer types discussed include breast, endocrine, hematologic, gastrointestinal, musculoskeletal, lung, skin and central nervous system cancers. The book is a valuable source for researchers and advanced students in cancer, biology, pharmacology, pharmaceutical sciences, biomaterials and medical/clinical sciences that are interested in accessing a comprehensive compendium on efflux pumps in mechanisms of cancer resistance. - Offers comprehensive and detailed descriptions of the basic aspects of efflux pumps in a very schematic and didactic manner - Describes the involvement of efflux pumps in cancer resistance in different cancer types - Encompasses an updated overview on state-of-the-art approaches that capitalize on their inhibition to improve chemotherapy and overcome resistance
Mitochondrial Function
Author:
Publisher: Academic Press
ISBN: 0128016159
Category : Science
Languages : en
Pages : 529
Book Description
This new volume of Methods in Enzymology continues the legacy of this premier serial with quality chapters authored by leaders in the field. Methods to assess mitochondrial function is of great interest to neuroscientists studying chronic forms of neurodegeneration, including Parkinson's, Alzheimer's, ALS, Huntington's and other triplet repeat diseases, but also to those working on acute conditions such as stroke and traumatic brain injury. This volume covers research methods on how to assess the life cycle of mitochondria including trafficking, fusion, fission, and degradation. Multiple perspectives on the complex and difficult problem of measurement of mitochondrial reactive oxygen species production with fluorescent indicators and techniques ranging in scope from measurements on isolated mitochondria to non-invasive imaging of metabolic function. - Continues the legacy of this premier serial with quality chapters authored by leaders in the field - Covers research methods in biomineralization science - Provides invaluable details on state-of-the-art methods to assess a broad array of mitochondrial functions
Publisher: Academic Press
ISBN: 0128016159
Category : Science
Languages : en
Pages : 529
Book Description
This new volume of Methods in Enzymology continues the legacy of this premier serial with quality chapters authored by leaders in the field. Methods to assess mitochondrial function is of great interest to neuroscientists studying chronic forms of neurodegeneration, including Parkinson's, Alzheimer's, ALS, Huntington's and other triplet repeat diseases, but also to those working on acute conditions such as stroke and traumatic brain injury. This volume covers research methods on how to assess the life cycle of mitochondria including trafficking, fusion, fission, and degradation. Multiple perspectives on the complex and difficult problem of measurement of mitochondrial reactive oxygen species production with fluorescent indicators and techniques ranging in scope from measurements on isolated mitochondria to non-invasive imaging of metabolic function. - Continues the legacy of this premier serial with quality chapters authored by leaders in the field - Covers research methods in biomineralization science - Provides invaluable details on state-of-the-art methods to assess a broad array of mitochondrial functions
Biomedical Imaging
Author: Peter Morris
Publisher: Elsevier
ISBN: 0857097474
Category : Technology & Engineering
Languages : en
Pages : 367
Book Description
Biomedical Imaging: Applications and Advances discusses the technologies and latest developments in the increasingly important field of imaging techniques for the diagnosis of disease, monitoring of medical implants, and strategies for personalized medicine. Chapters in part one explore the full range of imaging technologies from atomic force microscopy (AFM) to positron emission tomography (PET), as well as the next-generation techniques that could provide the basis for personalized medicine. Part two highlights application-specific biomedical imaging methods, including ophthalmic imaging of ocular circulation, imaging methods for detection of joint degeneration, neural brain activation imaging, and the use of brain imaging to assess post-therapy responses. Further chapters review intravascular, cardiovascular, and whole-body magnetic resonance imaging (MRI). Biomedical Imaging is a technical resource for those concerned with imaging and diagnosis, including materials scientists and engineers as well as clinicians and academics. - Explores the full range of imaging technologies from atomic force microscopy (AFM) to positron emission tomography (PET), as well as next-eneration techniques for personalized medicine - Highlights application-specific biomedical imaging methods, including ophthalmic imaging of ocular circulation, imaging methods for detection of joint degeneration, neural brain activation imaging, and the use of brain imaging to assess post therapy responses - Reviews intravascular, cardiovascular, and whole-body magnetic resonance imaging (MRI)
Publisher: Elsevier
ISBN: 0857097474
Category : Technology & Engineering
Languages : en
Pages : 367
Book Description
Biomedical Imaging: Applications and Advances discusses the technologies and latest developments in the increasingly important field of imaging techniques for the diagnosis of disease, monitoring of medical implants, and strategies for personalized medicine. Chapters in part one explore the full range of imaging technologies from atomic force microscopy (AFM) to positron emission tomography (PET), as well as the next-generation techniques that could provide the basis for personalized medicine. Part two highlights application-specific biomedical imaging methods, including ophthalmic imaging of ocular circulation, imaging methods for detection of joint degeneration, neural brain activation imaging, and the use of brain imaging to assess post-therapy responses. Further chapters review intravascular, cardiovascular, and whole-body magnetic resonance imaging (MRI). Biomedical Imaging is a technical resource for those concerned with imaging and diagnosis, including materials scientists and engineers as well as clinicians and academics. - Explores the full range of imaging technologies from atomic force microscopy (AFM) to positron emission tomography (PET), as well as next-eneration techniques for personalized medicine - Highlights application-specific biomedical imaging methods, including ophthalmic imaging of ocular circulation, imaging methods for detection of joint degeneration, neural brain activation imaging, and the use of brain imaging to assess post therapy responses - Reviews intravascular, cardiovascular, and whole-body magnetic resonance imaging (MRI)
Dose Finding in Drug Development
Author: Naitee Ting
Publisher: Springer Science & Business Media
ISBN: 0387337067
Category : Medical
Languages : en
Pages : 262
Book Description
If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.
Publisher: Springer Science & Business Media
ISBN: 0387337067
Category : Medical
Languages : en
Pages : 262
Book Description
If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.
PET/CT in Infection and Inflammation
Author: Thomas Wagner
Publisher: Springer
ISBN: 3319904124
Category : Medical
Languages : en
Pages : 112
Book Description
This pocket book provides clinicians with the necessary information to understand the role of FDG PET/CT in infection and inflammation. It will help both in making appropriate imaging requests with adequate clinical information and in interpreting the report. The coverage encompasses a wide range of topics, including the role of PET/CT in pyrexia of unknown origin, vasculitis, autoimmune diseases, prosthetic joint infections, osteomyelitis and diabetic foot, immunodeficiency disease, and vascular graft surgery. The book will be a very useful guide to a great test that can provide significant assistance in patient management. It is published within the Springer series Clinicians’ Guides to Radionuclide Hybrid Imaging, in which leading professionals succinctly explain the importance of nuclear medicine in the diagnosis and management of oncological and non-oncological conditions.
Publisher: Springer
ISBN: 3319904124
Category : Medical
Languages : en
Pages : 112
Book Description
This pocket book provides clinicians with the necessary information to understand the role of FDG PET/CT in infection and inflammation. It will help both in making appropriate imaging requests with adequate clinical information and in interpreting the report. The coverage encompasses a wide range of topics, including the role of PET/CT in pyrexia of unknown origin, vasculitis, autoimmune diseases, prosthetic joint infections, osteomyelitis and diabetic foot, immunodeficiency disease, and vascular graft surgery. The book will be a very useful guide to a great test that can provide significant assistance in patient management. It is published within the Springer series Clinicians’ Guides to Radionuclide Hybrid Imaging, in which leading professionals succinctly explain the importance of nuclear medicine in the diagnosis and management of oncological and non-oncological conditions.
Molecular Imaging
Author: Shankar Vallabhajosula
Publisher: Springer Science & Business Media
ISBN: 3540767355
Category : Medical
Languages : en
Pages : 379
Book Description
Radioisotope-based molecular imaging probes provide unprecedented insight into biochemistry and function involved in both normal and disease states of living systems, with unbiased in vivo measurement of regional radiotracer activities offering very high specificity and sensitivity. No other molecular imaging technology including functional magnetic resonance imaging (fMRI) can provide such high sensitivity and specificity at a tracer level. The applications of this technology can be very broad ranging from drug development, pharmacokinetics, clinical investigations, and finally to routine diagnostics in radiology. The design and the development of radiopharmaceuticals for molecular imaging studies using PET/MicroPET or SPECT/MicroSPECT are a unique challenge. This book is intended for a broad audience and written with the main purpose of educating the reader on various aspects including potential clinical utility, limitations of drug development, and regulatory compliance and approvals.
Publisher: Springer Science & Business Media
ISBN: 3540767355
Category : Medical
Languages : en
Pages : 379
Book Description
Radioisotope-based molecular imaging probes provide unprecedented insight into biochemistry and function involved in both normal and disease states of living systems, with unbiased in vivo measurement of regional radiotracer activities offering very high specificity and sensitivity. No other molecular imaging technology including functional magnetic resonance imaging (fMRI) can provide such high sensitivity and specificity at a tracer level. The applications of this technology can be very broad ranging from drug development, pharmacokinetics, clinical investigations, and finally to routine diagnostics in radiology. The design and the development of radiopharmaceuticals for molecular imaging studies using PET/MicroPET or SPECT/MicroSPECT are a unique challenge. This book is intended for a broad audience and written with the main purpose of educating the reader on various aspects including potential clinical utility, limitations of drug development, and regulatory compliance and approvals.
Biomarkers in Drug Development
Author: Michael R. Bleavins
Publisher: John Wiley & Sons
ISBN: 1118210425
Category : Medical
Languages : en
Pages : 559
Book Description
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
Publisher: John Wiley & Sons
ISBN: 1118210425
Category : Medical
Languages : en
Pages : 559
Book Description
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.