Pharmaceuticals Manufacturing Handbook
from C.H.I.P.S.

Preclinical Development Handbook
ADME and Biopharmaceutical Properties
edited by
Shayne Cox Gad

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.


  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


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

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Preclinical Development Handbook
ADME and Biopharmaceutical Properties
by Shayne Cox Gad

2008 • 1,329 pages • $194.00 + shipping
Texas residents please add 6.75 % sales tax

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