Dosage Form Design Parameters, Volume II examines the history as well as the current state of the field within pharmaceutical sciences and concisely explains the history of dosage form design including key developments. The contents are extrapolated to include drug development issues, scale up of formulations, regulatory issues and intellectual property. It also incorporates solid state properties and polymorphism. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of dosage form design parameters within the pharmaceutical sciences industry and research, as well as chemical engineering. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists. This book provides a comprehensive examination suitable for researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, and related industries as well as advanced students in these fields. Examines the history and most recent developments in drug dosage forms for pharmaceutical sciencesFocus on physicochemical aspects, prefomulation solid state properties and polymorphismContains extensive references for further discovery and learning appropriate for advanced undergraduate and graduate students, as well as those needing a quick understanding of drug dosage design INDICE: 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 through put screening, high through put 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
- ISBN: 9780128144213
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 575
- Fecha Publicación: 01/05/2018
- Nº Volúmenes: 1
- Idioma: Inglés