Handbook of Preformulation : Chemical, Biological, and Botanical Drugs, Second Edition

Description

Content: Cover Half Title Title Page Copyright Page Dedication Table of Contents Preface to the Second Edition Other Selected Books by Author Author 1: Drug Discovery Trends 1.1 Introduction 1.1.1 Genome Editing 1.1.2 Microbiome 1.1.3 Antibiotics 1.1.4 Artificial Intelligence 1.1.5 Marijuana 1.1.6 Target-Based Discovery 1.1.7 High-Through Screening 1.1.8 Rational Drug Design 1.1.9 Target Family Knowledge 1.1.10 DNA-Encoded Library Technology 1.1.11 Phenotype 1.1.12 Biologics 1.1.13 Botanicals 1.2 The Preformulation Focus 1.3 Development Phases 1.3.1 Stage 1: Lead Finding or Establishing Directions (1-2 Years)1.3.2 Stage 2: Candidate Drug Screening (1-10 Years) 1.3.3 Stage 3: Candidate Drug Selection (1-2 Years) 1.3.4 Stage 4: Preclinical Studies (1-2 Years) 1.3.5 Stage 5: Phase I Clinical Studies (1-2 Years) 1.3.6 Stage 6: Phase II and Phase III Studies and Launch (4-6 Years) 1.3.7 Stage 7: Postmarket Surveillance (3-5 Years) 1.4 Phytomedicines 1.5 Recombinant Drugs Web References Bibliography 2: Intellectual Property Considerations 2.1 Introduction 2.2 Patenting Strategies 2.2.1 Patenting Systems 2.2.2 What Is a Patent?2.2.3 Patent Myths 2.2.4 What Is Not Patentable? 2.3 Patent Search 2.3.1 Internet Search Engines 2.3.2 Information Portals 2.3.3 Technical Databases 2.3.4 Patent Search and Intellectual Property Services 2.3.5 Patent Copies and Search Facilities 2.4 Components of a Patent Application 2.4.1 Drawing(s) (113) 2.4.2 Specification (112 ¶1) 2.4.3 Paragraph 1 35 USC 112 Requirements 2.4.4 Paragraph 2 35 USC 112 Requirement: Parts of a Claim 2.5 Understanding Claims 2.5.1 Reading a Claim 2.5.2 Punctuation of Claim 2.5.3 Definiteness of Claim 2.5.4 Narrowing of Claim2.5.5 Dependent Claims (112 ¶3 ¶4) 2.5.6 Multiple Dependent Claims (112 ¶5) 2.5.7 Dominant-Subservient Claims 2.5.8 Means-Plus-Function Clauses 112 ¶6 2.5.9 Process Claims 2.5.10 Step-Plus-Function Clauses 2.5.11 Ranges 2.5.12 Negative Limitations 2.5.13 Relative and Exemplary Terminology 2.5.14 Markush Group 2.5.15 Markush Alternates 2.5.16 Jepson-Type Claims-Improvement Claims 2.5.17 Mixed-Class Claims 2.5.18 Product-by-Process Claims 2.5.19 Patent Term Adjustment 2.5.20 Patent and Trademark Office Delays: Guaranteed Adjustment Basis 2.5.21 Required Reduction Basis2.6 Food and Drug Administration Web References Bibliography Recommended Reading 3: The Scope of Preformulation Studies 3.1 Introduction 3.2 Preformulation Testing Criteria 3.3 Regulatory Requirements 3.3.1 Small Molecules/General 3.3.2 Phytomedicines 3.3.3 Large-Molecule Drugs 3.3.4 Recombinant DNA Products 3.4 Testing Systems 3.4.1 Polymorph Screening 3.4.2 pKa, Partitioning, and Solubility 3.4.3 Salt Screening 3.5 Solid-State Characterization 3.5.1 Powder Properties 3.5.2 Microscopy 3.5.3 Thermal Analysis 3.5.4 Molecular Spectroscopy