Pharmaceutical Medicine and Translational Clinical Research.

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Vohora, Divya
Otros Autores: Singh, Gursharan
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Saint Louis : Elsevier Science, 2017.
Temas:
Clinical medicine > Research.
Research Design
Médecine clinique > Recherche.
Clinical medicine > Research
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Cover
  • Pharmaceutical Medicine and Translational Clinical Research
  • Copyright Page
  • Contents
  • List of Contributors
  • About the Editors
  • Foreword
  • Preface
  • I. Overview of Pharmaceutical Medicine
  • 1 The Specialty of Pharmaceutical Medicine
  • 1.1 What is Pharmaceutical Medicine?
  • 1.2 Origin and Development of Pharmaceutical Medicine
  • 1.3 Present State of the Specialty of Pharmaceutical Medicine
  • 1.4 State of Affairs in Pharmaceutical Medicine in Selected Countries
  • 1.4.1 Hungary
  • 1.4.2 India
  • 1.4.3 Mexico
  • 1.4.4 Switzerland1.4.5 UK
  • 1.4.6 Emerging Countries
  • 1.5 Conclusions and Outlook
  • References
  • II. Drug Discovery and Development
  • 2 Drug Discovery and Development: An overview
  • 2.1 Introduction
  • 2.2 Identification of Unmet Medical Need
  • 2.3 Target Identification
  • 2.4 Target Validation
  • 2.5 Hit Identification and Development of Assays
  • 2.6 Confirmation of Hits
  • 2.7 Lead Generation
  • 2.8 Lead Optimization
  • 2.9 Preclinical Drug Development
  • 2.10 Criteria to Select a Clinical Candidate
  • 2.11 Clinical Drug development
  • 2.12 Other Approaches in Drug Discovery and Development2.13 Conclusion
  • Acknowledgments
  • References
  • 3 Pharmaceutical Development
  • 3.1 Introduction
  • 3.2 Elements of Pharmaceutical Development
  • 3.2.1 Quality Target Product Profile
  • 3.2.2 Critical Quality Attributes (CQA)
  • 3.2.3 Risk Assessment: Linking Material Attributes and Process Parameters to Drug Product CQAs
  • 3.2.4 Preformulation
  • 3.2.4.1 Drug substance
  • 3.2.4.2 Excipients
  • 3.2.4.3 Overages
  • 3.2.4.4 Physicochemical and Biological Properties
  • 3.2.5 Design Space
  • 3.2.6 Formulation Development3.2.6.1 Prototype development
  • 3.2.7 Control Strategy
  • 3.2.8 Scaleup and Stability Study of Batch
  • 3.2.9 Analytical Method Validation
  • 3.2.10 Documentation
  • 3.2.10.1 IPR and regulatory clearance
  • 3.2.10.2 Technology transfer dossier
  • 3.2.10.3 Technology transfer from R & D to production
  • 3.2.10.4 Master formula card (MFC) includes
  • 3.2.10.5 Master packaging card
  • 3.2.10.6 Master formula
  • 3.2.10.7 Specifications and standard test procedure (STPs)
  • 3.2.11 Exhibit Batch Manufacturing
  • 3.2.11.1 Validation batch3.2.11.2 The validation report
  • 3.2.11.3 Pivotal BE Studies
  • 3.2.11.4 Dossier Compilation and filling
  • 3.2.12 Product Lifecycle Management and Continual Improvement
  • 3.3 Conclusion
  • References
  • 4 Preclinical Drug Development
  • 4.1 Introduction
  • 4.2 Pharmacokinetic and Metabolism Studies
  • 4.3 Safety Pharmacology Studies
  • 4.3.1 Introduction and Objectives
  • 4.3.2 Route/Dose and Duration
  • 4.3.3 Type of Safety Pharmacology Studies
  • 4.3.4 Timing of Safety Pharmacology Studies
  • 4.4 Toxicology Studies

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