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Integrated pharmaceutics : applied preformulation, product design, and regulatory science /

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Bibliographic Details
Main Author:	Al-Achi, Antoine, 1955-
Other Authors:	Gupta, Mali Ram, Stagner, William Craig
Format:	eBook
Language:	English
Published:	Hoboken, N.J. : John Wiley & Sons, ©2013.
Subjects:	Pharmaceutical chemistry. Drugs > Design. Drugs > Dosage forms. Drugs > Standards. Biopharmaceutics. Chemistry, Pharmaceutical Drug Design Biopharmaceutics Dosage Forms > standards Drug and Narcotic Control Dosage Forms Electronic books.
Online Access:	Connect to the full text of this electronic book

Table of Contents:

PART I REFORMULATION
Chapter 1 Mathematical Concepts
Chapter 2 Thermodynamics
Chapter 3 Solubility and Dissolution
Chapter 4 Biological Aspects of Formulations
Chapter 5 Interfacial Properties
Chapter 6 Adsorption Phenomenon
Chapter 7 Rheological Principles
Chapter 8 Chemical Stability and Shelf-Life Determination
Chapter 9 Particle Science
Chapter 10 Basic Statistics and Design of Experimental Concepts
Chapter 11 Formulation Development Concepts
PART II PRODUCT DESIGN
Chapter 12 The Product Design Process
Chapter 13 Tablet Product Design
Chapter 14 Capsule Product Design
Chapter 15 Dispersed System Product Design
Chapter 16 Aerosol Product Design
Chapter 17 Sterile Injectable Product Design
Chapter 18 Ophthalmic Product Design
Chapter 19 Transdermal Product Design
Chapter 20 Oral Modified-Release Product Design
PART III REGULATORY SCIENCE
Chapter 21 Regulatory Practices and Guidelines
Chapter 22 Regulations for Compounding Pharmacies
Chapter 23 IND and NDA Phase-Appropriate New Drug Development Process
Chapter 24 Generics, Biosimilars, and OTCS
Chapter 25 Accelerated New Drug Approval and Expedited Access of New
Chapter 26 Post-Drug Approval Activities
Chapter 27 Drug Master Files and EU Dossiers
Chapter 28 Commissioning and Qualification
Chapter 29 Quality Systems and Controls
Chapter 30 Safety, Toxicology, and Pharmacogenomics
Chapter 31 Regulatory Science Initiatives for Advancing Public Health.