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Published by: Drug and Market Development Publishing
Published: Dec. 1, 2005 - 55 Pages
Table of Contents
Chapter 1: Introduction
Chapter 2: Pre-clinical Drug Discovery
Introduction
Biology of the Disease
Selecting a Drug Target
Target Types
DNA
RNA
Protein
Protein Drug Targets
Identification of Drug targets: Tools and Techniques
Chapter 3: Drug Target Identification and Validation
Target Identification
Molecular Biology Techniques
DNA-Related Techniques
RNA-Related Techniques
Protein Related Techniques
Genomic Related Techniques
Bioinformatics Techniques
Drug Target Validation
DTV Techniques
Chapter 4: Developing the Drug Target
Combinatorial Chemistry
Small Molecule Libraries
HTS Assay
HTS Phenotypic Outcomes
Chapter 5: Developing Leads from Hits
Lead Optimization and Development
Chapter 6: Drug Development Process: From Lead to IND Filing
Drug Discovery and Development Logical Plan
Post-Discovery Process
Chemistry and Synthesis of Drug Molecules
Drug Development Phase
Pharmacology or In Vitro and Animal Model Efficacy
Route of Administration
Defining the Appropriate Dose
Defining the Right Animal Models
In vivo dosage
Drug Developability Stage
Preliminary Formulation Evaluation
Toxicity
Drug metabolism
Pre-Clinical Drug Development Stage
Drug Candidate Characterization
Formulation Development
Bioanalytical Chemistry Method Validation
IND-Directed Toxicology Studies
Pharmacokinetics and Drug Metabolism
Mechanism of Action Studies
Other Required IND Application Studies
Manufacturing Program
Quality Control Process
Clinical
Pharmacokinetics and Drug Metabolism
Mechanism of Action
Phase 1 Safety and Tolerance Study
Phase 2 Efficacy Studies
Phase 3 Definitive Safety and Efficacy Studies
Phase 4 Studies
Filing an IND Application
Chapter 7: Summary and Conclusions
Chapter 8: Additional Reading
Chapter 9: Appendices
Table of Exhibits
Exhibit 1.1: Drug Discovery and Development in Pharma Industry
Exhibit 1.2: Summary of Drug Discovery and Development Process
Exhibit 2.1: Business Aspects Driving Drug Discovery and Development
Exhibit 2.2: Evolution of Therapeutic Drug Discovery from Disease Analysis
Exhibit 2.3: Identification of Drug Target for Gleevac
Exhibit 2.4: Classification of Drug Targets Based upon Marketed Small Molecules
Exhibit 2.5: Classification of Drug Targets Based on Cellular Localization
Exhibit 2.6: Techniques for Identification of Potential Drug Targets
Exhibit 2.7: Therapeutic Targets and Targeting Molecules, Advantages and
Disadvantages
Exhibit 2.8: Kinase Targeting Therapeutic Molecules
Exhibit 3.1: Applying Bioinformatics for Drug Discovery and Development
Exhibit 4.1: Methods of Measuring the Affinity of Small Molecules for Proteins
Exhibit 5.1: Developing Lead Molecules from Hit Molecules
Exhibit 5.2: Strategies for Lead Optimization of Therapeutic Molecules
Exhibit 6.1: Flowchart Showing Paths from Discovery to IND
Exhibit 6.2: Flow Chart Showing Post IND Filing Drug Activities at FDA
Exhibit 7.1: Flow Chart Showing Major Steps in the Drug Discovery and
Development Steps
Appendix 1: Stepwise Guide to Antibody Development for Therapeutics
Appendix 2: Stepwise Guide to Small Molecule Development for Therapeutics
AbstractD&MD’s Discovery to IND Filing analyzes the preclinical discovery and post-discovery drug development process leading to the filing of a successful IND application. Get answers to crucial questions such as:
- What are the steps required for drug development required by FDA?
- What IND enabling studies are required by the FDA?
This publication provides an in depth review of the major steps as well as the modern techniques that are utilized in the discovery to IND filing process. This report gives the reader a detailed breakdown of the steps involved in the different stages of therapeutic drug discovery and development. It also provides detailed analysis of identification of small molecules using HTS and other strategies, as well as a detailed analysis of steps that are taken post discovery including animal testing, pK/pD analysis, toxicity testing and efficacy analysis.
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