Targeted Therapy for the Central Nervous System: Formulation, Clinical Challenges, and Regulatory Strategies

Targeted Therapy for Central Nervous System: Formulation, Clinical Challenges and Regulatory Strategies

Table of Contents:
Part I. Brief About Pathophysiology 1. Etiology and Treatment Challenges for Neurodegenerative Disorders 2. Etiology and Treatment Challenges for Neurotraumatic and Psychiatric Disorders 3. Barriers to Progress of Neurotherapeutics: Getting Drugs to the Brain Part II. Novel Formulation Strategies for Targeted Therapy 4. IGF-II Conjugated Nanocarrier for Brain Targeting 5. ApoE Potential in CNS Drugs Targeting and as CNS Therapeutic 6. Transferrin Functionalized Nanoparticles for Targeted Drug Delivery in Biological Systems 7. Surface Engineered Multimodal Magnetic Nanoparticles for Neurodegenerative Diseases 8. Tau Targeting Biomimetic Nanoparticles 9. Stem Cell Therapy as a Novel Concept to Combat CNS Disorders 10. SR-B1 Receptor Targeting in CNS Disorders 11. β- and γ-secretases as Therapeutic Targets for Alzheimer’s Disease 12. Minimally Invasive Nasal Depot (MIND) Technique for Direct BDNF AntagoNAT Delivery to the Brain 13. Immunosuppressive and Immunomodulatory Therapies 14. CRISPR/Cas9 Gene Editing: A New Hope for Alzheimer’s Disease 15. Artificial Intelligence: Ways and Means for Central Nervous System (CNS) Delivery 16. Carbon Dots as Versatile Nano-architectures for the Treatment of Neurological Disorders Part III. Clinical Challenges and Regulatory Updates 17. Animal Models for Clinical Evaluation 18. Medical Device Contributors: Abhishek Swarnkar, Viral Patel, Amit Patel, Manan Raval 19. Regulation of Nanomaterials and Nanomedicines for Clinical Applications 20. Regulatory Considerations for the use of Biomarkers and Personalized Medicine in CNS Drug Development 21. Regulatory Toxicology Testing for Pharmaceuticals 22. Emerging Challenges and Opportunities for Drug and Drug Product Registrations 23. CRISPR/Cas9 Gene Editing: A New Hope for Parkinson’s Disease

About the Author :
Dr. Viral Patel currently associated with Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Anand, Gujarat, India as an Assistant Professor. Previously she was serving as Senior Research Associate (Formulation and Development- Research & Development) at Baxter Pharmaceuticals India Private Limited, Ahmedabad, Gujarat, India. Over these years she has gained expertise in the field of pharmaceutical drug product development and technology transfer. She holds a doctorate degree from Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India. She is recipient of prestigious Inspire Fellowship, sponsored by Department of Science and Technology, Govt. of India to pursue her doctoral research. She has many research and review articles published in reputed journals to her credit. She has also written several book chapters published by renowned publishing houses. Dr. Mithun Singh Rajput works with the Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India as Assistant Professor. He has expertise in neuropharmacology and received his doctoral degree from the Faculty of Medicine, M.G.M. Medical College, Indore, India. He is a recipient of two years’ National Postdoctoral Fellowship from SERB, Department of Science and Technology, India and is associated with the research project as principal investigator. He has overall teaching and research experience of twelve years. His areas of interest include the diagnosis and mitigation strategies for various neurodegenerative disorders like Alzheimer’s disease and cerebral ischemia, diabetes associated cognitive impairment, etc. He has received five research grants from government agencies and universities. Dr. Rajput has two patents, published three book chapters and has edited four books. Dr. Rajput is credited with thirty-two publications in peer reviewed indexed journals. He has served many government funding agencies, and journals as a reviewer and editorial board member. Dr. Jigna Shah is currently working as a Professor and Head of the Department of Pharmacology at Institute of Pharmacy, Nirma University, Ahmedabad. She is actively involved in oncology and neurodegenerative disorder research. Currently, she is working as a Principal investigator on one externally funded GSBTM project and two research projects from GSBTM in the area of breast cancer. She has successfully completed five externally funded research projects from GSBTM, AICTE and GUJCOST. Her research has also allowed her to complete a few consultancy assignments in toxicity studies, oncology, neuropharmacology, gastroenterology, and wound healing. She is widely published, having published more than 60 research papers. Shah is active within her research community as a life member of professional organizations such as the Indian Pharmaceutical Association, the Indian Pharmacological Society, the Indian Society for Technical Education and the Indian Society of Pharmacovigilance. Dr. Tejal Mehta is currently working as a Professor and Director In-charge at the Institute of Pharmacy, Nirma University, Ahmedabad. She has done her PhD from Sardar Patel University and has over twenty years of teaching and research experience. Her area of research is dissolution enhancement of sparingly soluble drugs and formulation development of conventional and novel drug delivery systems using concepts of QbD-DoE. She has published more than 70 research papers in journals of national and international repute. She has also presented several papers in national and international conferences. She currently also serves as a reviewer of national and international journals in the research area of pharmaceutics and drug delivery. She is an active member of various societies, including the Society of Pharmacovigilance of India.