Principles and Practice of Pharmaceutical Medicine (eBook, PDF)
Redaktion: Edwards, Lionel D.; Stonier, Peter D.; Fox, Anthony W.
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Principles and Practice of Pharmaceutical Medicine (eBook, PDF)
Redaktion: Edwards, Lionel D.; Stonier, Peter D.; Fox, Anthony W.
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The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.
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- Produktdetails
- Verlag: John Wiley & Sons
- Seitenzahl: 800
- Erscheinungstermin: 1. Oktober 2010
- Englisch
- ISBN-13: 9781444325270
- Artikelnr.: 37339866
- Verlag: John Wiley & Sons
- Seitenzahl: 800
- Erscheinungstermin: 1. Oktober 2010
- Englisch
- ISBN-13: 9781444325270
- Artikelnr.: 37339866
Preface to the Third Edition. About the Editors. Section I Overview of
Pharmaceutical Medicine. 1 The Practice and Practitioners of Pharmaceutical
Medicine (Anthony W. Fox). 2 Pharmaceutical Medicine as a Medical Specialty
(Michael D. Young & Peter D. Stonier). 3 Clinical Research Education and
Training for Biopharmaceutical Staff (Peter Marks & Sheila Gwizdak).
Section II Drug Discovery and Development. 4 Drug Discovery: Design and
Development (Ronald R. Cobb & Leslie J. Molony). 5 Translational Medicine,
Pharmaceutical Physicians, Patients, and Payers (Robert Sands & Douglas
Roy). 6 Pharmaceutics (Anthony W. Fox). 7 Nonclinical Toxicology (Frederick
Reno). 8 Informed Consent (Anthony W. Fox). 9 Phase I: The First
Opportunity for Extrapolation from Animal Data to Human Exposure (Stephen
H. Curry, Helen H. DeCory, & Johan Gabrielsson). 10 Phase II and Phase III
Clinical Studies (Anthony W. Fox). 11 Phase IV Drug Development:
Post-marketing Studies (Lisa R. Johnson-Pratt). 12 Site Management (Barry
Miskin). 13 Good Clinical Practices (Lionel D. Edwards). 14 Quality
Assurance, Quality Control and Audit (Rita Hattemer-Apostel). 15 The Unique
Role of Over-the-Counter Medicine (Paul Starkey). Section III Special
Populations and Required Special Studies. 16 Drug Research in Older
Patients (Lionel D. Edwards). 17 Drug Development Research in Women (Lionel
D. Edwards). 18 Clinical Research in Children (Lionel D. Edwards). 19
Racial and Ethnic Issues in Drug Regulation (Lionel D. Edwards, J-M.
Husson, E. Labbe, C. Naito, M. Papaluca Amati, S. Walker, R.L., Williams, &
H. Yasurhara). 20 Special Populations: Hepatic and Renal Failure (Anthony
W. Fox). 21 Drug Interactions (Anthony W. Fox & Anne-Ruth van
Troostenburg). 22 Orphan Drugs (Bert Spilker). 23 QT Interval Prolongation
and Drug Development (Bruce H. Morimoto & Anthony W. Fox). Section IV
Applied Aspects. 24 Biotechnology Products and Their Development (David A.
Shapiro & Anthony W. Fox). 25 Health Economics (Daniel C. Malone, Edward P.
Armstrong, & Mirza I. Rahman). 26 Pharmacoeconomics: Economic and
Humanistic Outcomes (Raymond J. Townsend, Jane T. Osterhaus, & J. Gregory
Boyer). 27 Pharmacoepidemiology and the Pharmaceutical Physician (Hugh H.
Tilson). 28 Statistical Principles and Application in Biopharmaceutical
Research (Dan Anbar). 29 Data Management (T.Y. Lee, Michael Minor, & Lionel
D. Edwards). 30 Patient Compliance: Pharmionics, A New Discipline (Dr.
Jean-Michel Metry). 31 Monitoring Drug Concentrations in Clinical Practice
(Anthony W. Fox). 32 Generics (Gabriel Lopez & Thomas Hoxie). 33
Complementary Medicines (Anthony W. Fox). Section V Drug Regulation. 34
United States Regulations (William Kennedy & Lionel D Edwards). 35 Special
US Regulatory Procedures: Emergency and "Compassionate" INDs and
Accelerated Product Approvals (Anthony W. Fox). 36 The Development of Human
Medicines Control in Europe from Classical Times to the 21st Century (John
P. Griffin). 37 Medicines Regulation in the European Union (A-R. van
Troostenburg & G. Tabusso). 38 Japanese Regulations (Etienne Labbe). 39
Drug Registration and Pricing in the Middle East (Edda
Freidank-Mueschenborn & Anja Konig). 40 China's Regulated Pharmaceutical
Market (Yan Yan Li Starkey). 41 India's New Era in Pharmaceuticals (Darshan
Kulkarni). Section VI Medical Services. 42 Medical Affairs (Gregory P.
Geba). 43 Drug Labeling (Anthony W. Fox). 44 Data Mining (Mirza I. Rahman &
Robbert P. van Manen). 45 Risk Management in Product Approval and Marketing
(Anthony W. Fox). 46 Publishing Clinical Studies (Anthony W. Fox). 47
Organizing and Planning Local, Regional, National, and International
Meetings and Conferences (Zofia Dziewanowska & Linda Packard). 48 When
Things Go Wrong: Drug Withdrawals from the Market (Ronald D. Mann). 49
International Trials: Successful Planning and Conduct (Katie P.J. Wood).
Section VII Legal and Ethical Aspects of Pharmaceutical Medicine. 50
Introduction to Bioethics for Pharmaceutical Professionals (Andrew J.
Fletcher). 51 Pharmaceutical Medicine and the Law (Sarah Croft). 52 Fraud
and Misconduct in Clinical Research (Jane Barrett). Section VIII Business
Aspects. 53 The Multinational Corporations: Cultural Challenges, the
Legal/Regulatory Framework and the Medico-commercial Environment (R.
Drucker & R. Graham Hughes). 54 Advertising and Marketing (Jonathan
Belsey). 55 Pharmaceutical Product Liability (Han W. Choi & Jae Hong Lee).
56 Patents (Gabriel Lopez). 57 Outsourcing Clinical Drug Development
Activities to Contract Research Organizations (CROs): Critical Success
Factors (John R. Vogel). 58 The Impact of Managed Care on the US
Pharmaceutical Industry (Robert J. Chaponis, Christine Hanson-Divers, &
Marilyn J. Wells). Appendix: Useful Web Links. Index.
Preface to the Third Edition. About the Editors. Section I Overview of
Pharmaceutical Medicine. 1 The Practice and Practitioners of Pharmaceutical
Medicine (Anthony W. Fox). 2 Pharmaceutical Medicine as a Medical Specialty
(Michael D. Young & Peter D. Stonier). 3 Clinical Research Education and
Training for Biopharmaceutical Staff (Peter Marks & Sheila Gwizdak).
Section II Drug Discovery and Development. 4 Drug Discovery: Design and
Development (Ronald R. Cobb & Leslie J. Molony). 5 Translational Medicine,
Pharmaceutical Physicians, Patients, and Payers (Robert Sands & Douglas
Roy). 6 Pharmaceutics (Anthony W. Fox). 7 Nonclinical Toxicology (Frederick
Reno). 8 Informed Consent (Anthony W. Fox). 9 Phase I: The First
Opportunity for Extrapolation from Animal Data to Human Exposure (Stephen
H. Curry, Helen H. DeCory, & Johan Gabrielsson). 10 Phase II and Phase III
Clinical Studies (Anthony W. Fox). 11 Phase IV Drug Development:
Post-marketing Studies (Lisa R. Johnson-Pratt). 12 Site Management (Barry
Miskin). 13 Good Clinical Practices (Lionel D. Edwards). 14 Quality
Assurance, Quality Control and Audit (Rita Hattemer-Apostel). 15 The Unique
Role of Over-the-Counter Medicine (Paul Starkey). Section III Special
Populations and Required Special Studies. 16 Drug Research in Older
Patients (Lionel D. Edwards). 17 Drug Development Research in Women (Lionel
D. Edwards). 18 Clinical Research in Children (Lionel D. Edwards). 19
Racial and Ethnic Issues in Drug Regulation (Lionel D. Edwards, J-M.
Husson, E. Labbe, C. Naito, M. Papaluca Amati, S. Walker, R.L., Williams, &
H. Yasurhara). 20 Special Populations: Hepatic and Renal Failure (Anthony
W. Fox). 21 Drug Interactions (Anthony W. Fox & Anne-Ruth van
Troostenburg). 22 Orphan Drugs (Bert Spilker). 23 QT Interval Prolongation
and Drug Development (Bruce H. Morimoto & Anthony W. Fox). Section IV
Applied Aspects. 24 Biotechnology Products and Their Development (David A.
Shapiro & Anthony W. Fox). 25 Health Economics (Daniel C. Malone, Edward P.
Armstrong, & Mirza I. Rahman). 26 Pharmacoeconomics: Economic and
Humanistic Outcomes (Raymond J. Townsend, Jane T. Osterhaus, & J. Gregory
Boyer). 27 Pharmacoepidemiology and the Pharmaceutical Physician (Hugh H.
Tilson). 28 Statistical Principles and Application in Biopharmaceutical
Research (Dan Anbar). 29 Data Management (T.Y. Lee, Michael Minor, & Lionel
D. Edwards). 30 Patient Compliance: Pharmionics, A New Discipline (Dr.
Jean-Michel Metry). 31 Monitoring Drug Concentrations in Clinical Practice
(Anthony W. Fox). 32 Generics (Gabriel Lopez & Thomas Hoxie). 33
Complementary Medicines (Anthony W. Fox). Section V Drug Regulation. 34
United States Regulations (William Kennedy & Lionel D Edwards). 35 Special
US Regulatory Procedures: Emergency and "Compassionate" INDs and
Accelerated Product Approvals (Anthony W. Fox). 36 The Development of Human
Medicines Control in Europe from Classical Times to the 21st Century (John
P. Griffin). 37 Medicines Regulation in the European Union (A-R. van
Troostenburg & G. Tabusso). 38 Japanese Regulations (Etienne Labbe). 39
Drug Registration and Pricing in the Middle East (Edda
Freidank-Mueschenborn & Anja Konig). 40 China's Regulated Pharmaceutical
Market (Yan Yan Li Starkey). 41 India's New Era in Pharmaceuticals (Darshan
Kulkarni). Section VI Medical Services. 42 Medical Affairs (Gregory P.
Geba). 43 Drug Labeling (Anthony W. Fox). 44 Data Mining (Mirza I. Rahman &
Robbert P. van Manen). 45 Risk Management in Product Approval and Marketing
(Anthony W. Fox). 46 Publishing Clinical Studies (Anthony W. Fox). 47
Organizing and Planning Local, Regional, National, and International
Meetings and Conferences (Zofia Dziewanowska & Linda Packard). 48 When
Things Go Wrong: Drug Withdrawals from the Market (Ronald D. Mann). 49
International Trials: Successful Planning and Conduct (Katie P.J. Wood).
Section VII Legal and Ethical Aspects of Pharmaceutical Medicine. 50
Introduction to Bioethics for Pharmaceutical Professionals (Andrew J.
Fletcher). 51 Pharmaceutical Medicine and the Law (Sarah Croft). 52 Fraud
and Misconduct in Clinical Research (Jane Barrett). Section VIII Business
Aspects. 53 The Multinational Corporations: Cultural Challenges, the
Legal/Regulatory Framework and the Medico-commercial Environment (R.
Drucker & R. Graham Hughes). 54 Advertising and Marketing (Jonathan
Belsey). 55 Pharmaceutical Product Liability (Han W. Choi & Jae Hong Lee).
56 Patents (Gabriel Lopez). 57 Outsourcing Clinical Drug Development
Activities to Contract Research Organizations (CROs): Critical Success
Factors (John R. Vogel). 58 The Impact of Managed Care on the US
Pharmaceutical Industry (Robert J. Chaponis, Christine Hanson-Divers, &
Marilyn J. Wells). Appendix: Useful Web Links. Index.
"The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine." -- Financial Technology, 1 March 2011