Principles and Practice of Pharmaceutical Medicine
Eds.: Edwards, Lionel D.; Fox, Anthony W.; Stonier, Peter D.
Principles and Practice of Pharmaceutical Medicine
Eds.: Edwards, Lionel D.; Fox, Anthony W.; Stonier, Peter D.
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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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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.
Produktdetails
- Produktdetails
- Verlag: Wiley & Sons / Wiley-Blackwell
- Artikelnr. des Verlages: 1A405194720
- 3. Aufl.
- Seitenzahl: 816
- Erscheinungstermin: 20. Dezember 2010
- Englisch
- Abmessung: 257mm x 200mm x 42mm
- Gewicht: 1856g
- ISBN-13: 9781405194723
- ISBN-10: 1405194723
- Artikelnr.: 32073840
- Verlag: Wiley & Sons / Wiley-Blackwell
- Artikelnr. des Verlages: 1A405194720
- 3. Aufl.
- Seitenzahl: 816
- Erscheinungstermin: 20. Dezember 2010
- Englisch
- Abmessung: 257mm x 200mm x 42mm
- Gewicht: 1856g
- ISBN-13: 9781405194723
- ISBN-10: 1405194723
- Artikelnr.: 32073840
Lionel D Edwards MB, BS, LRCP, MRCS, DipRCOG, FFPM, is Senior Director of Medical Affairs for Novartis USA, and President of Pharma Pro Plus Inc., a drug development consulting company. Dr. Edwards has been involved in all aspects of clinical trials for over 33 years on many different research drug and devices in 10 therapeutic areas. Dr. Edwards is a Fellow of the Faculty of Pharmaceutical Medicine and an Adjunct Professor at Temple University Graduate School of Pharmacology. He has taught for the Pharmaceutical Education & Research Institute for over 12 years and was on the teaching faculty of the National Association of Physicians. He is a founder member of the American Academy of Pharmaceutical Physicians. Anthony W Fox BSc, MBBS, FFPM, FRCP, MD(Lond), DipPharmMedRCP, CBiol, FIBiol, FRSA is President of EBD Group, a consultancy with offices in San Diego and Munich. Tony is a liveryman guardant of the Worshipful Society of Apothecaries of London. He is an Adjunct (i.e., honorary) Associate Clinical Professor in the Skaggs School of Pharmacy and Pharmaceutical Sciences, at the University of California, San Diego. His publications span several areas of pharmaceutical medicine, e.g. regulation, pharmacology, clinical trials, pharmacovigilance, analgesics, migraine, genotoxicology, and metabolism, and he is named as inventor on several patents. He is on the editorial boards of several journals, and serves in a more senior capacity for two of them. Peter D Stonier BA, BSc, PhD, MBChB, MRCPsych, FRCP, FRCPE, FFPM has 29 years experience in pharmaceutical medicine. Peter is Director of Education and Training of the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians of the UK. He is Medical Director of Amdipharm Plc, and of Medical Resource Provider Axess Ltd, and Visiting Professor in pharmaceutical medicine at the University of Surrey, which under his direction introduced the first MSc degree in Pharmaceutical Medicine in 1993, which is now part of the Postgraduate Medical School of the University. His publications include edited works in human psychopharmacology, pharmaceutical medicine, clinical research, medical marketing, and careers in the pharmaceutical industry. He is a member of the Association of Pharmaceutical Physicians and Investigators (APPI). Professor Stonier has been elected a Fellow of the Royal Society for the encouragement of Arts, Manufactures and Commerce.
Contributors. Preface to the First Edition. Preface to the Second Edition.
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.
Contributors. Preface to the First Edition. Preface to the Second Edition.
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.
"This third edition offers a comprehensive reference on the subject of pharmaceutical medicine, a relatively new and very diverse field." -- Booknews, 1 April 2011
"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
"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