Analytical Scientists in Pharmaceutical Product Development Task Management and Practical Knowledge.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Xiao, Kangping
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Newark : John Wiley & Sons, Incorporated, 2020.
Temas:
Drug development.
Analytical chemistry.
Médicaments > Développement.
Chimie analytique.
chemical analysis.
Analytical chemistry
Drug development
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Cover
  • Title Page
  • Copyright Page
  • Contents
  • Preface
  • Chapter 1 Pharmaceutical Development at a Glance
  • 1.1 Prescription Medicinal Product Development
  • 1.1.1 Active Pharmaceutical Ingredient (API) Development
  • 1.1.2 Preclinical Research
  • 1.1.3 Clinical Research - Phase 1, Safety and Dosage
  • 1.1.4 Clinical Research - Phase 2, Efficacy and Side Effects
  • 1.1.5 Clinical Research - Phase 3, Efficacy and Monitoring of Adverse Reactions
  • 1.1.6 Clinical Research - Phase 4, Post-Market Safety Monitoring
  • 1.1.7 FDA Approval of a Prescription Medicine
  • 1.2 Over-the-Counter (OTC) Medicinal Product Development
  • 1.2.1 FDA Monograph System
  • 1.2.2 New Drug Application Process for an OTC Medicinal Product
  • 1.2.3 Clinical Trials in OTC Product Development
  • 1.2.4 Prescription to OTC Switch
  • References
  • Chapter 2 Analytics in Fast-Paced Product Development
  • 2.1 Overall Development Process for New Products
  • 2.2 Regulatory Strategy and Analytical Development
  • 2.2.1 NDA and ANDA Filing
  • 2.2.2 Module 3 (CMC) of Common Technical Document
  • 2.2.3 Supplements and Other Changes to an Approved NDA or ANDA
  • 2.2.3.1 Major Changes
  • Prior Approval Supplement
  • 2.2.3.2 Moderate Changes
  • CBE-30
  • 2.2.3.3 Moderate Changes
  • CBE
  • 2.2.3.4 Minor Changes
  • Annual Report
  • 2.2.4 Analytical Development with FDA Guidelines in Mind
  • 2.3 ICH Guidelines and Analytical Development
  • 2.4 Pharmacopoeia Monographs and Analytical Development
  • 2.5 Formulation Development and Analytical Development
  • 2.5.1 Method Development Based on an Ideal, Comprehensive Quality by Design
  • 2.5.2 Fit-for-Purpose, Teamwork, Knowledge Sharing, and Platform Approach
  • 2.6 Methods for Scale-Up and Manufacturing QC Laboratories
  • 2.7 Process Analytical Technology
  • 2.8 Quality Assurance, Compliance, and Analytical Development
  • References
  • Chapter 3 Effective, Efficient, and Innovative Analytical Development
  • 3.1 Task Management by Fishbone Diagrams and Time-Bars
  • 3.2 Project Management - Waterfall Versus Agile
  • 3.3 Resource and Cost Estimations
  • 3.4 Desired Skill Sets
  • 3.5 Analytical Scientists and Innovation
  • 3.5.1 Think Outside the Box
  • 3.5.2 Think Inside the Box
  • 3.5.3 Be Analytically Creative
  • References
  • Chapter 4 Analytical Chemistry and Separation Science at Molecular Level
  • 4.1 Ions and Ionic Strength
  • 4.2 Protonation and Deprotonation
  • 4.3 Hydrolysis of Salts
  • 4.4 Charge-Dipole and Dipole-Dipole Interaction
  • 4.5 Hydrogen Bonding
  • 4.6 Electron Donor-Acceptor Interaction
  • 4.7 Hydration and Solvation Energy
  • 4.8 Hydrophobic Interactions
  • 4.9 Events Happening on the Column Surface
  • 4.10 Example Thought Processes of Chromatographic Method Development
  • 4.10.1 General Considerations
  • 4.10.2 Case Study - Method Development for Assay of Benzalkonium Chloride

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