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

Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development.Entirely focused on preformulation principles, this fully revised and updated**__Handbook of Preforumulation: Chemical, Biological, and Botanical Drugs, Second Edition__**provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.Features:Addresses the preformulation studies of three different types of new active entities - chemical, biological, and botanical, which is the latest established class of active ingredient classified by the FDA Illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects Includes extensive flow charts for characterization decision making Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization Includes over 50% new material 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 Preformulation Studies Are The Physical, Chemical, And Biological Studies Needed To Characterize A Drug Substance For Enabling The Proper Design Of A Drug Product, Whereas The Effectiveness Of A Drug Product Is Determined During The Formulation Studies Phase. Though The Two Disciplines Overlap In Practice, Each Is A Significantly Distinct Phase Of New Drug Development. Entirely Focused On Preformulation Principles, This Fully Revised And Updated Handbook Of Preformulation: Chemical, Biological, And Botanical Drugs, Second Edition Provides Detailed Descriptions Of Preformulation Methodologies, Gives A State-of-the-art Description Of Each Technique, And Lists The Currently Available Tools Useful In Providing A Comprehensive Characterization Of A New Drug Entity. Features: Addresses The Preformulation Studies Of Three Different Types Of New Active Entities - Chemical, Biological, And Botanical, Which Is The Latest Established Class Of Active Ingredient Classified By The Fda Illustrates The Activities Comprised In Preformulation Studies And Establishes A Method Of Tasking For Drug Development Projects Includes Extensive Flow Charts For Characterization Decision Making Gives Extensive Theoretical Treatment Of Principles Important For Testing Dissolution, Solubility, Stability, And Solid State Characterization Includes Over 50% New Material Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preforumulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity