The Process of New Drug Discovery and Development 


The Process of New Drug Discovery and Development, Second Edition presents a practical methodology and up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. This new addition updates the scientific advances in new drug discovery and development for areas such as combinatorial chemistry, screening technologies, metabonomics, biotechnology approaches and preclinical testing. It also greatly expands the focus on the business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development, such as the financial aspects of starting up a pharmaceutical enterprise, the regulatory process, liability and litigation, and patent law.

The Process of New Drug Discovery and Development | Charles G. Smith | CRC

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Table of Contents

Chapter 1. Drug Discovery and Development: An Overview of Modern Methods and Principles
Drug Discovery and Development from 20,000 Feet, Target Selection: The First Step Forward, Hit Identification: Finding a Starting Point, Identify a Clinical Candidate: Juggling the Properties

Chapter 2: The Drug Discovery Process: From Ancient Times to the Present Day
The Age of Botanicals: Preindustrial Drug Discovery, Paul Ehrlich: The Father of Modern Drug Discovery, Milestones in Drug Discovery, The Rise of Biologics and Macromolecular Therapeutics, Societal and Governmental Impacts, Regulatory Milestones, Future Developments in Drug Discovery

Chapter 3. Classical Targets in Drug Discoverym
Protein Structure, Enzymes, Inhibition of Enzymes, G-Protein-Coupled Receptors, Ion Channels, Membrane Transport Proteins Emerging Targets

Chapter 4: In vitro Screening Systems
The Language of Screening: Basic Terms, Streptavidin and Biotin, Biochemical versus Cellular Assays, Assay Systems and Methods of Detection, Radioligand Assay Systems, Enzyme-Linked Immunosorbent Assay (ELISA), Fluorescence-Based Assay Systems, Reporter Gene Assays, Kinetic Fluorescent Measurement Systems, Label-Free Assay Systems, Electrophysiological Patch Clamp, General Consideration for All Screening Methods

Chapter 5: Medicinal Chemistry
Structure–Activity Relationships and Structure–Property Relationships, The Role of Chirality, Push and Pull in structure–activity relationships, Quantitative Structure–Activity Relationships, The Pharmacophore, Developing an SAR Data Set, The Structure–Activity Relationship Cycle, Bioisosterism, Structure–Activity Relationship, Selectivity And Physicochemical Properties, “Druglike” Guidelines

Chapter 6: In vitro ADME and In vivo Pharmacokinetics
Absorption, Distribution, Elimination Pathways

Chapter 7: Animal Models of Disease States
Sources of Animal Models, Validity of Animal Models, Species Selection, Number of Animals, Exemplary Animal Models by Disease Category, Animal Models of Infectious Disease, Animal Models of Oncology

Chapter 8: Safety and Toxicology
Sources of Toxicity, Acute versus Chronic Toxicity, Cytotoxicity, Carcinogenicity, Genotoxicity, and Mutagenicity, Drug–Drug Interactions, Cardiovascular Safety and Toxicology Studies, Central Nervous System Safety and Toxicology Studies, Immune System Mediated Safety Issues






Written by Venkadesh Narayanan

Venkadesh is a Mechanical Engineer and an MBA with 30 years of experience in the domains of supply chain management, business analysis, new product development, business plan and standard operating procedures. He is currently working as Principal Consultant at Fhyzics Business Consultants. He is also serving as President, PDMA-India (an Indian affiliate of PDMA, USA) and Recognised Instructor of APICS, USA and CIPS, UK. He is a former member of Indian Civil Services (IRAS). Fhyzics offers consulting, certification, and executive development programs in the domains of supply chain management, business analysis and new product development.

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