Targeted Therapy for the 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. �- and ?-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

Authors

Viral Patel Assistant Professor, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Anand, Gujarat, India. 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. Mithun Singh Rajput Assistant Professor, Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India. Dr. Mithun Singh Rajput currently works for the Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat India as an Assistant Professor. He received his doctoral degree from Faculty of Medicine, M.G.M. Medical College, Indore, India and is a recipient of two years' National Postdoctoral Fellowship from SERB, Department of Science and Technology, India. His area of interest includes diagnosis and mitigating strategies for various neurodegenerative disorders like Alzheimer's disease and cerebral ischemia, diabetes associated cognitive impairment etc. He is currently supervising research scholars for master's and doctoral dissertations. Rajput has one patent and three book chapters published and has edited four books, and has been credited with over thirty publications. Jigna Shah Professor and Head, Department of Pharmacology at Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India. 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. Tejal Mehta Professor and Director In-charge, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India. 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.