Over the last 10 years there have been many changes in the development, control, and regulation of transdermal and topical products. Various quality issues have been reported by patients and practitioners resulting in the recall or removal of products from the market. With chapters written by experts in this field, this book takes a 21st century
Over the last 10 years there have been many changes in the development, control, and regulation of transdermal and topical products. Various quality issues have been reported by patients and practitioners resulting in the recall or removal of products from the market. With chapters written by experts in this field, this book takes a 21st century
Tapash K. Ghosh is employed by the Office of Clinical Pharmacology and Biopharmaceutics at CDER, FDA. Before joining the FDA, he held faculty positions in the division of pharmaceutical sciences at the Massachusetts College of Pharmacy in Boston and Howard University in Washington, DC. He is the author of numerous scientific publications and the principle editor of other scientific books.
Inhaltsangabe
Dermal and Transdermal Drug Delivery Systems: An Overview and Recent Advancements. Preclinical and Clinical Safety Assessment of Transdermal and Topical Dermatological Products. Selection Considerations for Membranes and Models for In Vitro/ Ex Vivo Permeation Studies. Design, Development, Manufacturing, and Testing of Transdermal Drug Delivery Systems. Quality by Design (QbD) Principles in the Development of Transdermal Drug Delivery Products. Microneedles for Drug Delivery: Industrial and Regulatory Perspectives. Biopharmaceutics Aspects of Dermally Applied Drug Delivery Systems. Quality and Performance Tests for Dermal Drug Delivery Systems. Perspective on Clinical Trials for Dermal Drug Delivery Systems. Regulatory Standards for Approval of Topical Dermatological Drug Products. Gaps and Future Considerations for Development of Transdermal and Topical Delivery Systems. Regulatory Challenges in Chemistry, Manufacturing and Controls: Gaps and Future Consideration for Locally Acting Topical Dermal Systems. Development of Topical and Transdermal Dosage Forms: Regulatory Perspective. Innovations and Future Prospects of Dermal Delivery Systems
Dermal and Transdermal Drug Delivery Systems: An Overview and Recent Advancements. Preclinical and Clinical Safety Assessment of Transdermal and Topical Dermatological Products. Selection Considerations for Membranes and Models for In Vitro/ Ex Vivo Permeation Studies. Design, Development, Manufacturing, and Testing of Transdermal Drug Delivery Systems. Quality by Design (QbD) Principles in the Development of Transdermal Drug Delivery Products. Microneedles for Drug Delivery: Industrial and Regulatory Perspectives. Biopharmaceutics Aspects of Dermally Applied Drug Delivery Systems. Quality and Performance Tests for Dermal Drug Delivery Systems. Perspective on Clinical Trials for Dermal Drug Delivery Systems. Regulatory Standards for Approval of Topical Dermatological Drug Products. Gaps and Future Considerations for Development of Transdermal and Topical Delivery Systems. Regulatory Challenges in Chemistry, Manufacturing and Controls: Gaps and Future Consideration for Locally Acting Topical Dermal Systems. Development of Topical and Transdermal Dosage Forms: Regulatory Perspective. Innovations and Future Prospects of Dermal Delivery Systems
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