Dosage Form Design Parameters. Volume II. Advances in Pharmaceutical Product Development and Research

Table of 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

Authors

Tekade, Rakesh K Dr Rakesh K Tekade, Assistant Professor of the Department of Pharmaceutics, investigates the design, development and characterization of targeted nanotechnology based formulations for the site specific delivery of therapeutic drugs, siRNA, microRNA, plasmids, proteins and peptide for the treatment of cancer. His current research encompasses development of novel polymeric nanomaterial for effective cytosolic delivery of anticancer bioactives. Dr Tekade's research is focused on designing a new generation of nanoparticles, which could identify the cancer cells and selectively deliver anticancer drugs and genes to inhibit the growth of cancer while sparing healthy tissues. His research work involves the applications of polymer chemistry, nanotechnology, molecular biology, pharmacokinetics/pharmacodynamics and imaging techniques. Dr Tekade has also investigated the anticancer activity and molecular mechanism of several compounds and nanoformulations against cancer cell lines. Dr Tekade has over 70 publications, 01 patent, 7 book chapters, and 3 editorial articles. He has delivered several invited research talks and presented research finding in more than 30 scientific conferences.