Full Description
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
1. Levels of solid state properties: Role of different levels during pharmaceutical development
2. Polymorphism and its Implications in Pharmaceutical Product Development
3. Basics of crystallization process applied in drug research
4. Role of amorphous state in drug delivery
5. Particulate level properties and its implications on product performance and processing
6. Bulk level properties and its role in formulation development and processing
7. Concepts of hypothesis testing and types of errors
8. Experimental design and analysis of variance
9. Basic concept and application of Sampling procedures
10. Statistical techniques in Pharmaceutical Product Development
11. Drug-excipient interaction and incompatibilities
12. Documentation protocols in product development department including clinical records
13. Correlation between in-vitro and in-vivo screens: Special emphasis on high throughput screening, high throughput pharmacokinetic analysis
14. Sterilization of pharmaceuticals: Technology, Equipment and Validation
15. Package development of pharmaceutical products: Aspects of packaging materials used for Pharmaceutical Products
16. Package types for different dosage forms
17. Food and drug laws effecting pharmaceutical product design, development and commercial manufacturing
18. Guiding Principles for Human and Animal Research during pharmaceutical product development
19. Applications of Computer in Pharmaceutical Product Development
20. Patents and other intellectual property rights in drug delivery
21. Computer Aided Prediction of Pharmacokinetic (ADMET) Properties
22. Ethics and Legal Protection of Uses of Computer Applications in Pharmaceutical Research
