Biopharmaceutics Modeling and Simulations: Theory, Practice, Methods, and Applications

✍ Scribed by Kiyohiko Sugano(auth.)

• Year: 2012
• Tongue: English
• Leaves: 515
• Category: Library

✦ Synopsis

A comprehensive introduction to using modeling and simulation programs in drug discovery and development

Biopharmaceutical modeling has become integral to the design and development of new drugs. Influencing key aspects of the development process, including drug substance design, formulation design, and toxicological exposure assessment, biopharmaceutical modeling is now seen as the linchpin to a drug's future success. And while there are a number of commercially available software programs for drug modeling, there has not been a single resource guiding pharmaceutical professionals to the actual tools and practices needed to design and test safe drugs.

A guide to the basics of modeling and simulation programs, Biopharmaceutics Modeling and Simulations offers pharmaceutical scientists the keys to understanding how they work and are applied in creating drugs with desired medicinal properties. Beginning with a focus on the oral absorption of drugs, the book discusses:

• The central dogma of oral drug absorption (the interplay of dissolution, solubility, and permeability of a drug), which forms the basis of the biopharmaceutical classification system (BCS)
• The concept of drug concentration
• How to simulate key drug absorption processes
• The physiological and drug property data used for biopharmaceutical modeling
• Reliable practices for reporting results

With over 200 figures and illustrations and a peerless examination of all the key aspects of drug research?including running and interpreting models, validation, and compound and formulation selection?this reference seamlessly brings together the proven practical approaches essential to developing the safe and effective medicines of tomorrow.

Content:
Chapter 1 Introduction (pages 1–9):
Chapter 2 Theoretical Framework I: Solubility (pages 10–32):
Chapter 3 Theoretical Framework II: Dissolution (pages 33–63):
Chapter 4 Theoretical Framework III: Biological Membrane Permeation (pages 64–121):
Chapter 5 Theoretical Framework IV: Gastrointestinal Transit Models and Integration (pages 122–159):
Chapter 6 Physiology of Gastrointestinal Tract and Other Administration Sites in Humans and Animals (pages 160–205):
Chapter 7 Drug Parameters (pages 206–265):
Chapter 8 Validation of Mechanistic Models (pages 266–321):
Chapter 9 Bioequivalence and Biopharmaceutical Classification System (pages 322–339):
Chapter 10 Dose and Particle Size Dependency (pages 340–346):
Chapter 11 Enabling Formulations (pages 347–378):
Chapter 12 Food Effect (pages 379–411):
Chapter 13 Biopharmaceutical Modeling for Miscellaneous Cases (pages 412–429):
Chapter 14 Intestinal Transporters (pages 430–451):
Chapter 15 Strategy in Drug Discovery and Development (pages 452–458):
Chapter 16 Epistemology of Biopharmaceutical Modeling and Good Simulation Practice (pages 459–463):