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Inclusion [[electronic resource] ] : the politics of difference in medical research / / Steven Epstein
Inclusion [[electronic resource] ] : the politics of difference in medical research / / Steven Epstein
Autore Epstein Steven
Edizione [1st ed.]
Pubbl/distr/stampa Chicago, : University of Chicago Press, 2007
Descrizione fisica 1 online resource (427 p.)
Disciplina 610.72
Collana Chicago studies in practices of meaning
Soggetto topico Medicine - Research - Social aspects - United States
Human experimentation in medicine - Social aspects - United States
Clinical trials - Social aspects - United States
Minorities - Medical care - United States
Health and race - United States
Social medicine - United States
Soggetto non controllato inclusion, difference, race, gender, medical research, medicine, healthcare, diversity, advocacy groups, clinical trials, public health, bias, human experimentation, compliance, recruitment, sex differences, women, black, african american, underserved communities, biology, social justice, inequality, inequity, nonfiction, science, politics, reform, progress
ISBN 1-281-95679-1
9786611956790
0-226-21311-0
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto How to study a biopolitical paradigm -- Histories of the human subject -- The rise of resistance : framing the critique of the standard human -- The path to reform : aligning categories, targeting the state -- Opposition to reform : controversy, closure, and boundary work -- Formalizing the new regime -- From the standard human to niche standardization -- Counts and consequences : monitoring compliance -- The science of recruitmentology and the politics of trust -- To profile or not to profile : what difference does race make? -- Sex differences and the new politics of women's health -- Whither the paradigm?
Record Nr. UNINA-9910812453503321
Epstein Steven  
Chicago, : University of Chicago Press, 2007
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Lo trovi qui: Univ. Federico II
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The Indian journal of medical research
The Indian journal of medical research
Pubbl/distr/stampa New Delhi : , : Indian Council of Medical Research, , c1994-
Descrizione fisica 1 online resource : illustrations
Disciplina 610.72
Soggetto topico Medicine
Research
Soggetto genere / forma Periodical
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Record Nr. UNISA-996199882703316
New Delhi : , : Indian Council of Medical Research, , c1994-
Materiale a stampa
Lo trovi qui: Univ. di Salerno
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The Indian journal of medical research
The Indian journal of medical research
Pubbl/distr/stampa New Delhi : , : Indian Council of Medical Research, , c1994-
Descrizione fisica 1 online resource : illustrations
Disciplina 610.72
Soggetto topico Medicine
Research
Soggetto genere / forma Periodical
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Record Nr. UNINA-9910142988203321
New Delhi : , : Indian Council of Medical Research, , c1994-
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The Indian journal of medical research
The Indian journal of medical research
Pubbl/distr/stampa Calcutta, : Published for Indian Research Fund Association by Thacker, Spink & Co., 1913-1988
Descrizione fisica 1 online resource
Disciplina 610.72
Soggetto topico Medicine
Medicine - Research
Research
Médecine
Médecine - Recherche
Recherche
44.00 medicine: general
Geneeskunde
Soggetto genere / forma Periodical
Periodicals.
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Record Nr. UNISA-996200613803316
Calcutta, : Published for Indian Research Fund Association by Thacker, Spink & Co., 1913-1988
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The Indian journal of medical research
The Indian journal of medical research
Pubbl/distr/stampa Calcutta, : Published for Indian Research Fund Association by Thacker, Spink & Co., 1913-1988
Descrizione fisica 1 online resource
Disciplina 610.72
Soggetto topico Medicine
Medicine - Research
Research
Médecine
Médecine - Recherche
Recherche
44.00 medicine: general
Geneeskunde
Soggetto genere / forma Periodical
Periodicals.
Formato Materiale a stampa
Livello bibliografico Periodico
Lingua di pubblicazione eng
Record Nr. UNINA-9910143824003321
Calcutta, : Published for Indian Research Fund Association by Thacker, Spink & Co., 1913-1988
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Lo trovi qui: Univ. Federico II
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Intellectual Property and Health Technologies [[electronic resource] ] : Balancing Innovation and the Public's Health / / by Joanna T. Brougher
Intellectual Property and Health Technologies [[electronic resource] ] : Balancing Innovation and the Public's Health / / by Joanna T. Brougher
Autore Brougher Joanna T
Edizione [1st ed. 2014.]
Pubbl/distr/stampa New York, NY : , : Springer New York : , : Imprint : Springer, , 2014
Descrizione fisica 1 online resource (223 p.)
Disciplina 344.0321
610
610.72
613
Soggetto topico Public health
Medicine
Medical laws and legislation
Public Health
Biomedicine, general
Medical Law
ISBN 1-4614-8202-X
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""Preface""; ""Acknowledgments""; ""Contents""; ""1 Introduction to Intellectual Property""; ""Introduction""; ""The Meaning of ��Intellectual Property��""; ""Types of Intellectual Property Protection""; ""Copyright""; ""Trademarks""; ""Trade Secrets""; ""Patents""; ""Requirements""; ""Underlying Theory of Intellectual Property""; ""Basis of Intellectual Property Law""; ""The U.S. Patent System""; ""United States Patent and Trademark Office""; ""Supreme Court""; ""Congress""; ""Summary""; ""References""; ""2 Obtaining, Enforcing and Defending Patents""; ""Obtaining Patent Protection""
""Patentable Subject Matter""""Utility""; ""Novelty""; ""Nonobviousness""; ""Written Description and Enablement""; ""Enforcement of Patents""; ""Types of Patent Infringement""; ""Determination of Infringement""; ""Remedies for Infringement""; ""Defenses""; ""Invalidity""; ""Inequitable Conduct""; ""Exhaustion""; ""Exhaustion and Self-Replicating Technologies""; ""Experimental Use""; ""Five Important Facts to Remember About Patents""; ""Summary""; ""References""; ""3 Gene Patents""; ""History of Gene Patenting""; ""Chakrabarty and the Rise of Gene Patents""; ""Chakrabarty�s Legacy""
""The Harvard Oncomouse and the Patenting of Higher Level Life Forms""""The Current Controversy""; ""Public Health Implications""; ""Access to Medical Treatment""; ""Quality of Medical Treatment""; ""Innovation""; ""Summary""; ""References""; ""4 Medical Procedure Patents""; ""History of Medical Procedure Patents""; ""The Patent Law Compromise""; ""Who is Protected""; ""The Loophole for Medical Devices""; ""The Unenforceable Patent Right""; ""Medical Procedure Patents as ��Process�� Under Section 101""
""A Possible Shift in the Trend: In re Bilski and the ��Machine or Transformation�� Test""""Aftermath of Bilski""; ""Immunizations: Classen Immunotherapies, Inc. v. Biogen""; ""In Vitro Diagnostics: Prometheus Laboratories, Inc. v. Mayo Collaborative Services""; ""Diagnostic Testing: Myriad Genetics v. Association for Molecular Pathology (AMP)""; ""Public Health Implications""; ""Ethical Issues""; ""Academic Access""; ""Patient Privacy""; ""Access to Medical Treatment""; ""Impact on Innovation""; ""Infringement Liability""; ""Summary""; ""References""
""5 Rights and Roles of Universities and Inventors""""Researcher and Inventor""; ""Publish or Perish""; ""Determining Inventorship""; ""The Bayh-Dole Act: Stimulating Commercialization of University Research""; ""IP Policies and Assignment Provisions""; ""Stanford v. Roche""; ""Government�s March-in Rights""; ""Effects of the Bayh-Dole Act""; ""Technology Transfer: Transferring University Technology to the Private Sector""; ""Summary""; ""References""; ""6 Drug Development: Managing the Patent and FDA Processes""; ""Overview of Drug Development""
""Reconciling Patent Protection with the Drug Development Process""
Record Nr. UNINA-9910300082903321
Brougher Joanna T  
New York, NY : , : Springer New York : , : Imprint : Springer, , 2014
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Interpreting biomedical science : experiment, evidence, and belief / / Ülo Maiväli
Interpreting biomedical science : experiment, evidence, and belief / / Ülo Maiväli
Autore Maiväli Ülo
Pubbl/distr/stampa London, England ; ; San Diego, California : , : Academic Press, an imprint of Elsevier, , 2015
Descrizione fisica 1 online resource (416 p.)
Disciplina 610.72
Soggetto topico Medicine - Research - Methodology
Medical sciences - Research
ISBN 0-12-419956-9
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Interpreting Biomedical Science: Experiment, Evidence, and Belief; Copyright Page; Contents; Preface; Acknowledgments; Introduction; Science Made Easy; Did the Greeks Get their Math Right but their Science Wrong?; The Scientific Revolution; Deduction and Induction as Two Approaches to Scientific Inference; References; I. What Is at Stake: The Skeptical Argument; 1 Do We Need a Science of Science?; 1.1 Are We Living in the Golden Age of Science?; 1.2 R&D and the Cost of Medicine; 1.3 The Efficiency of Drug Discovery; 1.4 Factors that Endanger the Quality of Medical Evidence
1.5 The Stability of Evidence-Based Medical Practices1.6 Reproducibility of Basic Biomedical Science; 1.6.1 Genome-Wide Association Studies; 1.6.2 Microarray Studies; 1.6.3 Proteomics; 1.6.4 Small Science; 1.7 Is Reproducibility a Good Criterion of Quality of Research?; 1.8 Is Biomedical Science Self-Correcting?; 1.9 Do We Need a Science of Science?; References; 2 The Basis of Knowledge: Causality and Truth; 2.1 Scientific Realism and Truth; 2.2 Hume's Gambit; 2.3 Kant's Solution; 2.4 Why Induction Is Poor Deduction; 2.5 Popper's Solution; 2.6 Why Deduction Is Poor Induction
2.7 Does Lung Cancer Cause Smoking?2.8 Correlation, Concordance, and Regression; 2.8.1 Correlation; 2.8.2 Concordance; 2.8.3 Regression; 2.9 From Correlation to Causation; 2.10 From Experiment to Causation; 2.11 Is Causality a Scientific Concept?; References; II. The Method; 3 Study Design; 3.1 Why Do Experiments?; 3.2 Population and Sample; 3.3 Regression to the Mean; 3.4 Why Repeat an Experiment?; 3.5 Technical Versus Biological Replication of Experiments; 3.6 Experimental Controls; 3.6.1 Example 1. Negative Controls; 3.6.2 Example 2. Normalization Controls
3.6.3 Example 3. Controlling the Controls3.7 Multiplicities; 3.8 Conclusion: How to Design an Experiment; References; 4 Data and Evidence; 4.1 Looking at Data; 4.2 Modeling Data; 4.3 What Is Probability?; 4.3.1 Bayesian Probability; 4.3.2 Frequentist Probability; 4.3.3 Propensity Theory of Probability; 4.4 Assumptions Behind Frequentist Statistical Tests; 4.5 The Null Hypothesis; 4.6 The P value; 4.6.1 What the P Value Is Not; 4.7 Neyman-Pearson Hypothesis Testing; 4.8 Multiple Testing in the Context of NPHT; 4.9 P Value as a Measure of Evidence; 4.10 The "Error Bars"
4.11 Likelihood as an Unbiased Measure of Evidence4.12 Conclusion: Ideologies Behind Some Methods of Statistical Inference; References; 5 Truth and Belief; 5.1 From Long-Run Error Probabilities to Degrees of Belief; 5.2 Bayes Theorem: What Makes a Rational Being?; 5.3 Testing in the Infinite Hypothesis Space: Bayesian Parameter Estimation; 5.4 All Against All: Bayesianism Versus Frequentism Versus Likelihoodism; 5.5 Bayesianism as a Philosophy; 5.6 Bayesianism and the Progress of Science; 5.7 Conclusion to Part II; References; III. The Big Picture; 6 Interpretation
6.1 Hypothesis Testing at Small Samples
Record Nr. UNINA-9910797243303321
Maiväli Ülo  
London, England ; ; San Diego, California : , : Academic Press, an imprint of Elsevier, , 2015
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Interpreting biomedical science : experiment, evidence, and belief / / Ülo Maiväli
Interpreting biomedical science : experiment, evidence, and belief / / Ülo Maiväli
Autore Maiväli Ülo
Pubbl/distr/stampa London, England ; ; San Diego, California : , : Academic Press, an imprint of Elsevier, , 2015
Descrizione fisica 1 online resource (416 p.)
Disciplina 610.72
Soggetto topico Medicine - Research - Methodology
Medical sciences - Research
ISBN 0-12-419956-9
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Interpreting Biomedical Science: Experiment, Evidence, and Belief; Copyright Page; Contents; Preface; Acknowledgments; Introduction; Science Made Easy; Did the Greeks Get their Math Right but their Science Wrong?; The Scientific Revolution; Deduction and Induction as Two Approaches to Scientific Inference; References; I. What Is at Stake: The Skeptical Argument; 1 Do We Need a Science of Science?; 1.1 Are We Living in the Golden Age of Science?; 1.2 R&D and the Cost of Medicine; 1.3 The Efficiency of Drug Discovery; 1.4 Factors that Endanger the Quality of Medical Evidence
1.5 The Stability of Evidence-Based Medical Practices1.6 Reproducibility of Basic Biomedical Science; 1.6.1 Genome-Wide Association Studies; 1.6.2 Microarray Studies; 1.6.3 Proteomics; 1.6.4 Small Science; 1.7 Is Reproducibility a Good Criterion of Quality of Research?; 1.8 Is Biomedical Science Self-Correcting?; 1.9 Do We Need a Science of Science?; References; 2 The Basis of Knowledge: Causality and Truth; 2.1 Scientific Realism and Truth; 2.2 Hume's Gambit; 2.3 Kant's Solution; 2.4 Why Induction Is Poor Deduction; 2.5 Popper's Solution; 2.6 Why Deduction Is Poor Induction
2.7 Does Lung Cancer Cause Smoking?2.8 Correlation, Concordance, and Regression; 2.8.1 Correlation; 2.8.2 Concordance; 2.8.3 Regression; 2.9 From Correlation to Causation; 2.10 From Experiment to Causation; 2.11 Is Causality a Scientific Concept?; References; II. The Method; 3 Study Design; 3.1 Why Do Experiments?; 3.2 Population and Sample; 3.3 Regression to the Mean; 3.4 Why Repeat an Experiment?; 3.5 Technical Versus Biological Replication of Experiments; 3.6 Experimental Controls; 3.6.1 Example 1. Negative Controls; 3.6.2 Example 2. Normalization Controls
3.6.3 Example 3. Controlling the Controls3.7 Multiplicities; 3.8 Conclusion: How to Design an Experiment; References; 4 Data and Evidence; 4.1 Looking at Data; 4.2 Modeling Data; 4.3 What Is Probability?; 4.3.1 Bayesian Probability; 4.3.2 Frequentist Probability; 4.3.3 Propensity Theory of Probability; 4.4 Assumptions Behind Frequentist Statistical Tests; 4.5 The Null Hypothesis; 4.6 The P value; 4.6.1 What the P Value Is Not; 4.7 Neyman-Pearson Hypothesis Testing; 4.8 Multiple Testing in the Context of NPHT; 4.9 P Value as a Measure of Evidence; 4.10 The "Error Bars"
4.11 Likelihood as an Unbiased Measure of Evidence4.12 Conclusion: Ideologies Behind Some Methods of Statistical Inference; References; 5 Truth and Belief; 5.1 From Long-Run Error Probabilities to Degrees of Belief; 5.2 Bayes Theorem: What Makes a Rational Being?; 5.3 Testing in the Infinite Hypothesis Space: Bayesian Parameter Estimation; 5.4 All Against All: Bayesianism Versus Frequentism Versus Likelihoodism; 5.5 Bayesianism as a Philosophy; 5.6 Bayesianism and the Progress of Science; 5.7 Conclusion to Part II; References; III. The Big Picture; 6 Interpretation
6.1 Hypothesis Testing at Small Samples
Record Nr. UNINA-9910822207303321
Maiväli Ülo  
London, England ; ; San Diego, California : , : Academic Press, an imprint of Elsevier, , 2015
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Introduction to biological and small molecule drug research and development [[electronic resource] ] : theory and case studies / / edited by Robin Ganellin, Stanley Roberts, Roy Jefferis
Introduction to biological and small molecule drug research and development [[electronic resource] ] : theory and case studies / / edited by Robin Ganellin, Stanley Roberts, Roy Jefferis
Pubbl/distr/stampa Waltham, Mass., : Elsevier, 2013
Descrizione fisica 1 online resource (368 p.)
Disciplina 610.72
Altri autori (Persone) GanellinRobin
RobertsStanley
JefferisRoy
Soggetto topico Drug development
Soggetto genere / forma Electronic books.
ISBN 0-12-397770-3
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Introduction to Biological and Small Molecule Drug Research and Development: Theory and Case Studies; Copyright; Contents; Biographies; Preface; Chapter 1 - Introduction to enzymes, receptors and the action of small molecule drugs; 1.1 SECTION I: BACKGROUND INFORMATION; 1.2 SECTION II: MORE ABOUT ENZYMES; 1.3 SECTION III: MORE ABOUT RECEPTORS; 1.4 SECTION IV; Further Reading; Chapter 2 - Protein structure and function; 2.1 INTRODUCTION; 2.2 GENERAL ASPECTS OF PROTEIN STRUCTURE; 2.3 ENZYMES; 2.4 PROTEIN RECEPTORS; 2.5 STRUCTURAL PROTEINS AS DRUG TARGETS; 2.6 PROTEINS AS DRUGS
2.7 CONCLUDING REMARKSReferences; Chapter 3 - The small molecule drug discovery process - from target selection to candidate selection; 3.1 INTRODUCTION; 3.2 WHERE DO LEADS COME FROM?; 3.3 LEAD GENERATION: ACTIVE-TO-HIT; 3.4 LEAD GENERATION: HIT-TO-LEAD; 3.5 LO - ESTABLISHING THE SCREENING CASCADE AND CANDIDATE BIOLOGICAL TARGET PROFILE; References and Notes; Further Reading; Chapter 4 - Protein therapeutics (introduction to biopharmaceuticals); 4.1 INTRODUCTION; 4.2 TYPES OF PROTEIN THERAPEUTICS I: REGULATORY AND ENZYMATIC ACTIVITY; 4.3 TYPES OF PROTEIN THERAPEUTICS II: TARGETING ACTIVITY
4.4 CHALLENGES OF PROTEIN THERAPEUTICS4.5 FUTURE DIRECTIONS FOR PROTEIN THERAPEUTICS; 4.6 BIOSIMILAR PROTEIN THERAPEUTICS; 4.7 SUMMARY AND CONCLUSIONS; References; Further Reading; Chapter 5 - Similarities and differences in the discovery and use of biopharmaceuticals and small-molecule chemotherapeutics; 5.1 INTRODUCTION; 5.2 HOW DO SMDS DIFFER FROM BIOMOLECULAR DRUGS?; 5.3 HISTORICAL CHANGES TO THE FDA APPROACH TO HANDLE THE BIOTECH BOOM-THE DIFFERING NOMENCLATURE FOR SMALL MOLECULES VS BIOLOGI ...; 5.4 COMPARISONS OF CLINICAL METRICS-BIOLOGICS VS SMALL MOLECULES
5.5 ARE PEPTIDE DRUGS SMALL MOLECULES OR BIOLOGICS?5.6 THE MANUFACTURE AND SUPPLY OF SMDS VS BIOMOLECULAR DRUGS; 5.7 THE PRICING OF SMDS VS BIOMOLECULAR DRUGS; 5.8 COMPARING SMALL-MOLECULE, PEPTIDE AND BIOMOLECULAR DRUGS IN THE MARKET; 5.9 BIOSIMILAR BIOMOLECULES VS GENERIC SMALL MOLECULES; 5.10 DISCOVERY AND PRECLINICAL STAGES FOR SMDS VS BIOMOLECULAR DRUGS-WHERE THE TECHNOLOGIES DIFFER THE MOST; 5.11 SMALL-MOLECULE AND BIOLOGICS APPROVALS BY THERAPY AREAS; 5.12 MANAGING SMALL-MOLECULE & BIOMOLECULAR DRUG R&D IN THE SAME COMPANY; 5.13 CONCLUSION; References
Chapter 6 - Therapies for type 2 diabetes: modulating the incretin pathway using small molecule peptidase inhibitors or pep ...6.1 INTRODUCTION; 6.2 PHARMACOTHERAPY OF TYPE 2 DIABETES; 6.3 THE RATIONALE FOR INCRETIN-BASED THERAPIES FOR TYPE 2 DIABETES; 6.4 DISCOVERY AND PHARMACOKINETICS OF THE INCRETIN-BASED THERAPIES; 6.5 CLINICAL EFFICACY OF THE INCRETIN-BASED THERAPIES; 6.6 EVIDENCE FOR DISEASE MODIFICATION; 6.7 IMPACT ON CARDIOVASCULAR RISK; 6.8 CLINICAL SAFETY AND TOLERABILITY OF INCRETIN-BASED THERAPIES; 6.9 CONCLUSIONS; References
Chapter 7 - The structure and business of biopharmaceutical companies including the management of risks and resources
Record Nr. UNINA-9910459133703321
Waltham, Mass., : Elsevier, 2013
Materiale a stampa
Lo trovi qui: Univ. Federico II
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Introduction to biological and small molecule drug research and development : theory and case studies / / edited by Robin Ganellin, Stanley Roberts, Roy Jefferis
Introduction to biological and small molecule drug research and development : theory and case studies / / edited by Robin Ganellin, Stanley Roberts, Roy Jefferis
Pubbl/distr/stampa Waltham, Mass., : Elsevier, 2013
Descrizione fisica 1 online resource (xx, 425 pages, 21 unnumbered pages of plates) : illustrations (some color)
Disciplina 610.72
Collana Gale eBooks
Soggetto topico Drug development
Biopharmaceutics
ISBN 0-12-397770-3
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto Front Cover; Introduction to Biological and Small Molecule Drug Research and Development: Theory and Case Studies; Copyright; Contents; Biographies; Preface; Chapter 1 - Introduction to enzymes, receptors and the action of small molecule drugs; 1.1 SECTION I: BACKGROUND INFORMATION; 1.2 SECTION II: MORE ABOUT ENZYMES; 1.3 SECTION III: MORE ABOUT RECEPTORS; 1.4 SECTION IV; Further Reading; Chapter 2 - Protein structure and function; 2.1 INTRODUCTION; 2.2 GENERAL ASPECTS OF PROTEIN STRUCTURE; 2.3 ENZYMES; 2.4 PROTEIN RECEPTORS; 2.5 STRUCTURAL PROTEINS AS DRUG TARGETS; 2.6 PROTEINS AS DRUGS
2.7 CONCLUDING REMARKSReferences; Chapter 3 - The small molecule drug discovery process - from target selection to candidate selection; 3.1 INTRODUCTION; 3.2 WHERE DO LEADS COME FROM?; 3.3 LEAD GENERATION: ACTIVE-TO-HIT; 3.4 LEAD GENERATION: HIT-TO-LEAD; 3.5 LO - ESTABLISHING THE SCREENING CASCADE AND CANDIDATE BIOLOGICAL TARGET PROFILE; References and Notes; Further Reading; Chapter 4 - Protein therapeutics (introduction to biopharmaceuticals); 4.1 INTRODUCTION; 4.2 TYPES OF PROTEIN THERAPEUTICS I: REGULATORY AND ENZYMATIC ACTIVITY; 4.3 TYPES OF PROTEIN THERAPEUTICS II: TARGETING ACTIVITY
4.4 CHALLENGES OF PROTEIN THERAPEUTICS4.5 FUTURE DIRECTIONS FOR PROTEIN THERAPEUTICS; 4.6 BIOSIMILAR PROTEIN THERAPEUTICS; 4.7 SUMMARY AND CONCLUSIONS; References; Further Reading; Chapter 5 - Similarities and differences in the discovery and use of biopharmaceuticals and small-molecule chemotherapeutics; 5.1 INTRODUCTION; 5.2 HOW DO SMDS DIFFER FROM BIOMOLECULAR DRUGS?; 5.3 HISTORICAL CHANGES TO THE FDA APPROACH TO HANDLE THE BIOTECH BOOM-THE DIFFERING NOMENCLATURE FOR SMALL MOLECULES VS BIOLOGI ...; 5.4 COMPARISONS OF CLINICAL METRICS-BIOLOGICS VS SMALL MOLECULES
5.5 ARE PEPTIDE DRUGS SMALL MOLECULES OR BIOLOGICS?5.6 THE MANUFACTURE AND SUPPLY OF SMDS VS BIOMOLECULAR DRUGS; 5.7 THE PRICING OF SMDS VS BIOMOLECULAR DRUGS; 5.8 COMPARING SMALL-MOLECULE, PEPTIDE AND BIOMOLECULAR DRUGS IN THE MARKET; 5.9 BIOSIMILAR BIOMOLECULES VS GENERIC SMALL MOLECULES; 5.10 DISCOVERY AND PRECLINICAL STAGES FOR SMDS VS BIOMOLECULAR DRUGS-WHERE THE TECHNOLOGIES DIFFER THE MOST; 5.11 SMALL-MOLECULE AND BIOLOGICS APPROVALS BY THERAPY AREAS; 5.12 MANAGING SMALL-MOLECULE & BIOMOLECULAR DRUG R&D IN THE SAME COMPANY; 5.13 CONCLUSION; References
Chapter 6 - Therapies for type 2 diabetes: modulating the incretin pathway using small molecule peptidase inhibitors or pep ...6.1 INTRODUCTION; 6.2 PHARMACOTHERAPY OF TYPE 2 DIABETES; 6.3 THE RATIONALE FOR INCRETIN-BASED THERAPIES FOR TYPE 2 DIABETES; 6.4 DISCOVERY AND PHARMACOKINETICS OF THE INCRETIN-BASED THERAPIES; 6.5 CLINICAL EFFICACY OF THE INCRETIN-BASED THERAPIES; 6.6 EVIDENCE FOR DISEASE MODIFICATION; 6.7 IMPACT ON CARDIOVASCULAR RISK; 6.8 CLINICAL SAFETY AND TOLERABILITY OF INCRETIN-BASED THERAPIES; 6.9 CONCLUSIONS; References
Chapter 7 - The structure and business of biopharmaceutical companies including the management of risks and resources
Record Nr. UNINA-9910792478903321
Waltham, Mass., : Elsevier, 2013
Materiale a stampa
Lo trovi qui: Univ. Federico II
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