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