Preclinical Development Handbook: ADME and Biopharmaceutical Properties gives the professional pharmaceutical scientist a basic and comprehensive tool to facilitate the preclinical development process by bringing together an overview of the preclinical process and a compendium of methods and techniques that need to be considered when developing a new drug.

The book details steps in the preclinical process including:

• prioritizing and optimizing leads
• dose formulation
• ADME
• pharmacokinetics
• modelling
• regulations

Preclinical Development Handbook: ADME and Biopharmaceutical Properties includes problems that are encountered, solutions to these problems, and limitations of various methods and techniques used in determining the safety and efficacy of a drug at this stage.

Contents

1. Modeling and Informatics in Drug Design
2. Computer Techniques: Identifying Similarities Between Small Molecules
3. Protein–Protein Interactions
4. Method Development for Preclinical Bioanalytical Support
5. Analytical Chemistry Methods: Developments and Validation
6. Chemical and Physical Characterizations of Potential New Chemical Entity
7. Permeability Assessment
8. How and Where Are Drugs Absorbed?
9. Absorption of Drugs after Oral Administration
10. Distribution: Movement of Drugs through the Body
11. The Blood–Brain Barrier and Its Effect on Absorption and Distribution
12. Transporter Interactions in the ADME Pathway of Drugs
13. >Accumulation of Drugs in Tissues
14. Salt and Cocrystal Form Selection
15. Dissolution
16. Stability: Physical and Chemical
17. Dosage Formulation
18. Cytochrome P450 Enzymes
19. Metabolism Kinetics
20. Drug Clearance
21. In Vitro Metabolism in Preclinical Drug Development
22. Utilization of In Vitro Cytochrome P450 Inhibition Data for Projecting Clinical Drug–Drug Interactions
23. In Vivo Metabolism in Preclinical Drug Development
24. In Vitro Evaluation of Metabolic Drug–Drug Interactions: Scientific Concepts and Practical Considerations
25. Mechanisms and Consequences of Drug–Drug Interactions
26. Species Comparison of Metabolism in Microsomes and Hepatocytes
27. Metabolite Profi ling and Structural Identification
28. Linkage between Toxicology of Drugs and Metabolism
29. Allometric Scaling
30. Interrelationship between Pharmacokinetics and Metabolism
31. Experimental Design Considerations in Pharmacokinetic Studies
32. Bioavailability and Bioequivalence Studies
33. Mass Balance Studies
34. Pharmacodynamics
35. Physiologically Based Pharmacokinetic Modeling
36. Mathematical Modeling as a New Approach for Improving the Efficacy/Toxicity Profi le of Drugs: The Thrombocytopenia Case Study
37. Regulatory Requirements for INDs/FIH (First in Human) Studies
38. Data Analysis

Index

Also available:
Preclinical Development Handbook Volume 2: Toxicology
Preclinical Development Handbook 2-Volume Set

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