Bookedited by Rakesh K. Tekade.
Summary: Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.
Contents:
Front-matter
Copyright
Dedication
List of Contributors
About the Editor
Levels of Solid State Properties: Role of Different Levels During Pharmaceutical Product Development
Basics of Crystallization Process Applied in Drug Exploration
Role of Amorphous State in Drug Delivery
Particulate Level Properties and its Implications on Product Performance and Processing
Bulk Level Properties and its Role in Formulation Development and Processing
Concepts of Hypothesis Testing and Types of Errors
Experimental Design and Analysis of Variance
Basic Concept and Application of Sampling Procedures
Statistical Techniques in Pharmaceutical Product Development
Drug–Excipient Interaction and Incompatibilities
Documentation Protocol in Product Development Including Clinical Records
Correlation Between In Vitro and In Vivo Screens: Special Emphasis on High Throughput Screening and High Throughput Pharmacokinetic Analysis
Sterilization of Pharmaceuticals: Technology, Equipment, and Validation
Package Development of Pharmaceutical Products: Aspects of Packaging Materials Used for Pharmaceutical Products
Package Types for Different Dosage Forms
Food and Drug Laws Affecting Pharmaceutical Product Design, Development, and Commercial Manufacturing
Guiding Principles for Human and Animal Research During Pharmaceutical Product Development
Applications of Computers in Pharmaceutical Product Formulation
Patents and Other Intellectual Property Rights in Drug Delivery
Computer-Aided Prediction of Pharmacokinetic (ADMET) Properties
Ethics and Legal Protection of Uses of Computer Applications in Pharmaceutical Research
Index