Chapter 8 Clinical frontiers and regulatory status of micro/nanoemulsions
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Swarnali Das Paul
Abstract
Micro- and nanoemulsions represent a significant advancement in the field of drug deliverydelivery systems, offering enhanced bioavailabilitybioavailability, stability, and targeted deliverydelivery of therapeutic agents. This chapter explores the clinical frontiers and regulatory status of micro/nanoemulsions, focusing on the evolving landscape of their development, approval, and market access across different global regions. The first section delves into the regulatory considerations, highlighting the regulatory pathways established by key agenciesagencies such as the US FDAFDA, EMAEMA, and CDSCO, as well as the guidelines for quality, safety, and efficacy assessments.
In the comparative analysis section, we explore efforts toward harmonizing regulatory standards, with a specific emphasis on the International Council for Harmonization (ICH)International Council for Harmonization (ICH) guidelines and their relevance to nanotechnology. Additionally, insights into emerging regulatory frameworks for nanoformulations are provided, shedding light on the future regulatory environment.
The chapter further discusses the latest innovations in formulationformulation technologies, the role of micro/nanoemulsions in precision and personalized medicine, and the potential challenges facing their clinical and regulatory acceptance in the future. Finally, perspectives on the future of micro/nanoemulsions in healthcare are presented, followed by a conclusion that encapsulates the key themes of regulatory, clinical, and technological advancements in this rapidly evolving field. This chapter aims to provide a comprehensive overview for researchers, clinicians, and regulatory bodies engaged in the development and approval of micro/nanoemulsionnanoemulsion-based products.
Abstract
Micro- and nanoemulsions represent a significant advancement in the field of drug deliverydelivery systems, offering enhanced bioavailabilitybioavailability, stability, and targeted deliverydelivery of therapeutic agents. This chapter explores the clinical frontiers and regulatory status of micro/nanoemulsions, focusing on the evolving landscape of their development, approval, and market access across different global regions. The first section delves into the regulatory considerations, highlighting the regulatory pathways established by key agenciesagencies such as the US FDAFDA, EMAEMA, and CDSCO, as well as the guidelines for quality, safety, and efficacy assessments.
In the comparative analysis section, we explore efforts toward harmonizing regulatory standards, with a specific emphasis on the International Council for Harmonization (ICH)International Council for Harmonization (ICH) guidelines and their relevance to nanotechnology. Additionally, insights into emerging regulatory frameworks for nanoformulations are provided, shedding light on the future regulatory environment.
The chapter further discusses the latest innovations in formulationformulation technologies, the role of micro/nanoemulsions in precision and personalized medicine, and the potential challenges facing their clinical and regulatory acceptance in the future. Finally, perspectives on the future of micro/nanoemulsions in healthcare are presented, followed by a conclusion that encapsulates the key themes of regulatory, clinical, and technological advancements in this rapidly evolving field. This chapter aims to provide a comprehensive overview for researchers, clinicians, and regulatory bodies engaged in the development and approval of micro/nanoemulsionnanoemulsion-based products.
Kapitel in diesem Buch
- Frontmatter I
- Foreword V
- Foreword VII
- Contents V
- List of contributing authors IX
- Introduction 1
- Chapter 1 Techniques for characterizing micro/nanoemulsions in pharmaceutical formulations 9
- Chapter 2 Micro/nanoemulsions in dermatology for enhanced therapeutic solutions 49
- Chapter 3 Harnessing micro/nanoemulsion for transnasal drug delivery with enhanced efficacy and precision 79
- Chapter 4 Micro/nanoemulsions redefining cosmeceutical formulation for optimal skin health 107
- Chapter 5 Accelerating recovery through advanced wound healing applications of micro/nanoemulsions 127
- Chapter 6 Precision oncology: nanoemulsions as pioneers in the delivery of anticancer agents, immunomodulators, and vaccines 171
- Chapter 7 Cutting-edge innovations: advances and applications of micro/nanoemulsions in gel formulations 211
- Chapter 8 Clinical frontiers and regulatory status of micro/nanoemulsions 251
- Chapter 9 Future prospects of micro/nanoemulsions in enhancing drug performance 269
- Index 289
Kapitel in diesem Buch
- Frontmatter I
- Foreword V
- Foreword VII
- Contents V
- List of contributing authors IX
- Introduction 1
- Chapter 1 Techniques for characterizing micro/nanoemulsions in pharmaceutical formulations 9
- Chapter 2 Micro/nanoemulsions in dermatology for enhanced therapeutic solutions 49
- Chapter 3 Harnessing micro/nanoemulsion for transnasal drug delivery with enhanced efficacy and precision 79
- Chapter 4 Micro/nanoemulsions redefining cosmeceutical formulation for optimal skin health 107
- Chapter 5 Accelerating recovery through advanced wound healing applications of micro/nanoemulsions 127
- Chapter 6 Precision oncology: nanoemulsions as pioneers in the delivery of anticancer agents, immunomodulators, and vaccines 171
- Chapter 7 Cutting-edge innovations: advances and applications of micro/nanoemulsions in gel formulations 211
- Chapter 8 Clinical frontiers and regulatory status of micro/nanoemulsions 251
- Chapter 9 Future prospects of micro/nanoemulsions in enhancing drug performance 269
- Index 289
