Dermatological Drug Development

Dermatological Drug Development PDF Author: Tomoko Maeda-Chubachi
Publisher: Cambridge Scholars Publishing
ISBN: 152755967X
Category : Medical
Languages : en
Pages : 146

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Book Description
This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).

Dermatological Drug Development

Dermatological Drug Development PDF Author: Tomoko Maeda-Chubachi
Publisher: Cambridge Scholars Publishing
ISBN: 152755967X
Category : Medical
Languages : en
Pages : 146

Get Book Here

Book Description
This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).

Evidence-Based Dermatology

Evidence-Based Dermatology PDF Author: Hywel Williams
Publisher: John Wiley & Sons
ISBN: 9781444300178
Category : Medical
Languages : en
Pages : 740

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Book Description
Evidence-based Dermatology, Second Edition is aunique book in the field of clinical dermatology. Written andedited by some of the world’s leading experts inevidence-based dermatology, it takes a highly evidence-basedapproach to the treatment of all major and many of the less commonskin conditions. The toolbox at the beginning of the book explaining how tocritically appraise different studies, along with the comprehensivereviewing and appraisal of evidence in the clinical chapters makesthis book distinctive in its field as do the treatmentrecommendations which are based on the discussion of the bestavailable evidence using a question-driven approach and a commonstructure on dealing with efficacy, drawbacks and implications forclinical practice.

Drug Repurposing

Drug Repurposing PDF Author: Farid A. Badria
Publisher: BoD – Books on Demand
ISBN: 1839685204
Category : Medical
Languages : en
Pages : 236

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Book Description
Drug repurposing or drug repositioning is a new approach to presenting new indications for common commercial and clinically approved existing drugs. For example, chloroquine, an old antimalarial drug, showed promising results for treating COVID-19, interfering with MDR in several types of cancer, and chemosensitizing human leukemic cells.This book focuses on the hypothesis, risk/benefits, and economic impacts of drug repurposing on drug discovery in dermatology, infectious diseases, neurological disorders, cancer, and orphan diseases. It brings together up-to-date research to provide readers with an informative, illustrative, and easy-to-read book useful for students, clinicians, and the pharmaceutical industry.

Dermal Drug Delivery

Dermal Drug Delivery PDF Author: Tapash K. Ghosh
Publisher: CRC Press
ISBN: 1315356643
Category : Medical
Languages : en
Pages : 432

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Book Description
With the continued advancement of better-quality control and patient outcome reporting systems, changes in the development, control, and regulation of all pharmaceutical delivery systems including transdermal and topical products have been happening on a continuous basis. In light of various quality issues that have been reported by patients and practitioners resulting in the recall or removal of products from the market, both the pharmaceutical industries and regulatory agencies have been adopting new measures to address these issues. With chapters written by experts in this field, this book takes a 21st century multidisciplinary and cross-functional look at these dosage forms to improve the development, design, manufacturing, quality, clinical performance, safety, and regulation of these products. This book offers a wealth of up-to-date information organized in a logical sequence corresponding to various stages of research, development, and commercialization of dermal drug delivery products. The authors have been carefully selected from different sectors of pharmaceutical science for their expertise in their selected areas to present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their insights will provide useful information to others to ensure the successful development of the next generation dermal drug products. Key Features: Presents current advancements including new technologies of transdermal and topical dosage forms. Presents challenges in the development of the new generation of transdermal and topical dosage forms. Introduces new technologies and QbD (quality by design) aspects of manufacturing and control strategies. Includes new perspectives on pre-clinical and clinical development, regulatory considerations, safety and quality. Discusses regulatory challenges, gaps, and future considerations for dermal drug delivery systems.

Compounded Topical Pain Creams

Compounded Topical Pain Creams PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030967218X
Category : Medical
Languages : en
Pages : 353

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Book Description
Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

Comprehensive Dermatologic Drug Therapy

Comprehensive Dermatologic Drug Therapy PDF Author: Stephen E Wolverton
Publisher: Elsevier Health Sciences
ISBN: 0323612121
Category : Medical
Languages : en
Pages : 1073

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Book Description
Designed with practical usability in mind, Comprehensive Dermatologic Drug Therapy, 4th Edition, helps you safely and effectively treat the skin disorders you're likely to see in your practice. Dr. Stephen E. Wolverton and new associate editor Dr. Jashin J. Wu lead a team of global experts to bring you concise, complete guidance on today's full spectrum of topical, intralesional, and systemic drugs. You'll prescribe with confidence thanks to expert coverage of which drugs to use, when to use them, and adverse effects to monitor. - Includes new drug interaction tables, drug risk profiles, and FDA guidelines, as well as two new appendices that summarize chapter questions and summarize highest-risk drug interactions. - Covers the best uses for new biologic therapeutics. - Contains new chapters covering medical decision-making principles, PDE-4 and JAK inhibitors, interleukin 17 inhibitors, interleukin 23 inhibitors, additional biologic therapeutics, and hedgehog pathway inhibitors. - Contains quick-access summaries of indications/contraindications, dosage guidelines, drug interactions, drug monitoring guidelines, adverse effects, and treatment protocols. - Features a highly detailed, disease-specific index, as well as purchase information for major drugs. - Helps you assess your knowledge and prepare for certification or recertification with about 800 review questions and answers throughout the book. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices.

Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Drug Discovery and Evaluation: Methods in Clinical Pharmacology PDF Author: H.Gerhard Vogel
Publisher: Springer Science & Business Media
ISBN: 3540898905
Category : Medical
Languages : en
Pages : 576

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Book Description
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

Nanoscience in Dermatology

Nanoscience in Dermatology PDF Author: Michael R. Hamblin
Publisher: Academic Press
ISBN: 0128029455
Category : Science
Languages : en
Pages : 404

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Book Description
Nanoscience in Dermatology covers one of the two fastest growing areas within dermatological science, nanoscience and nanotechnology in dermatology. Recently, great progress has been made in the research and development of nanotechnologies and nanomaterials related to various applications in medicine and, in general, the life sciences. There is increasing enthusiasm for nanotechnology applications in dermatology (drug delivery, diagnostics, therapeutics, imaging, sensors, etc.) for understanding skin biology, improving early detection and treatment of skin diseases, and in the design and optimization of cosmetics. Light sensitive nanoparticles have recently been explored, opening a new era for the combined applications of light with nanotechnology, also called photonanodermatology. However, concerns have been raised regarding the adverse effects of intentional and unintentional nanoparticle exposure and their toxicity. Written by experts working in these exciting fields, this book extensively covers nanotechnology applications, together with the fundamentals and toxicity aspects. It not only addresses current applications of nanotechnology, but also discusses future trends of these ever-growing and rapidly changing fields, providing scientists and dermatologists with a clear understanding of the advantages and challenges of nanotechnology in skin medicine. - Provides knowledge of current and future applications of nanoscience and nanotechnology in dermatology - Outlines the fundamentals, methods, toxicity aspects, and other relevant aspects for nanotechnology based applications in dermatology - Coherently structured book written by experts working in the fields covered

Dermoscopy in General Dermatology

Dermoscopy in General Dermatology PDF Author: Aimilios Lallas
Publisher: CRC Press
ISBN: 1351782886
Category : Medical
Languages : en
Pages : 719

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Book Description
This lavishly illustrated guide from experts will enable practitioners to get the most out of dermoscopy for investigations and treatments in general dermatology.

Skin Tissue Engineering and Regenerative Medicine

Skin Tissue Engineering and Regenerative Medicine PDF Author: Mohammad Albanna
Publisher: Academic Press
ISBN: 012801797X
Category : Technology & Engineering
Languages : en
Pages : 468

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Book Description
The skin is the largest human organ system. Loss of skin integrity due to injury or illness results in a substantial physiologic imbalance and ultimately in severe disability or death. From burn victims to surgical scars and plastic surgery, the therapies resulting from skin tissue engineering and regenerative medicine are important to a broad spectrum of patients. Skin Tissue Engineering and Regenerative Medicine provides a translational link for biomedical researchers across fields to understand the inter-disciplinary approaches which expanded available therapies for patients and additional research collaboration. This work expands on the primary literature on the state of the art of cell therapies and biomaterials to review the most widely used surgical therapies for the specific clinical scenarios. - Explores cellular and molecular processes of wound healing, scar formation, and dermal repair - Includes examples of animal models for wound healing and translation to the clinical world - Presents the current state of, and clinical opportunities for, extracellular matrices, natural biomaterials, synthetic biomaterials, biologic skin substitutes, and adult and fetal stem and skin cells for skin regenerative therapies and wound management - Discusses new innovative approaches for wound healing including skin bioprinting and directed cellular therapies