Название: Pharmaceutical Product Development ISBN: 0367453177 ISBN-13(EAN): 9780367453176 Издательство: Taylor&Francis Рейтинг: Цена: 9492.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and pharmacokinetics are collaborating to address physicochemical and biological issues in the early stages of development to avoid problems in later stages. In Vitro-In Vivo Correlation (IVIVC) is a multidisciplinary tool that has been successfully applied in testing the effectiveness of a drug substance. The only comprehensive guide available on IVIVC, this source illustrates the emerging importance of IVIVC in the drug development process, and covers the most recent advances and regulatory perspectives on the role of IVIVC in the pharmaceutical industry.
Автор: Nigel Langley; Bozena Michniak-Kohn; David W. Osbo Название: The Role of Microstructure in Topical Drug Product Development ISBN: 3030173542 ISBN-13(EAN): 9783030173548 Издательство: Springer Рейтинг: Цена: 22359.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus: Particle/Globule Size and Distribution, Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content.
Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book. Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs). In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development’ crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.
Автор: Feroz Jameel; Susan Hershenson; Mansoor A. Khan; S Название: Quality by Design for Biopharmaceutical Drug Product Development ISBN: 1493923153 ISBN-13(EAN): 9781493923151 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development.
Автор: Uday B. Kompella; Henry F. Edelhauser Название: Drug Product Development for the Back of the Eye ISBN: 146142819X ISBN-13(EAN): 9781461428190 Издательство: Springer Рейтинг: Цена: 32651.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Selection of Drug Delivery Approaches for the Back of the Eye: Opportunities and Unmet Needs.- Microdialysis for Vitreal Pharmacokinetics.- Fluorophotometry for Pharmacokinetic Assessment.- Systemic Route for Retinal Drug Delivery: Role of the Blood-Retinal Barrier.- Topical Drug Delivery to the Back of the Eye.- Principles of Retinal Drug Delivery from Within the Vitreous.- Transscleral Drug Delivery.- Suprachoroidal and Intrascleral Drug Delivery.- Advances in Biodegradable Ocular Drug Delivery Systems.- Microparticles as Drug Delivery Systems for the Back of the Eye.- Nanotechnology and Nanoparticles.- Hydrogels for Ocular Posterior Segment Drug Delivery.- Refillable Devices for Therapy of Ophthalmic Diseases.- Targeted Drug Delivery to the Eye Enabled by Microneedles.- Ocular Iontophoresis.- Drug and Gene Therapy Mediated by Physical Methods.- Protein Drug Delivery and Formulation Development.- Drug Suspension Development for the Back of the Eye.- Regulatory Considerations in Product Development for Back of the Eye.- Clinical Endpoints for Back of the Eye Diseases.- Druggable Targets and Therapeutic Agents for Disorders of the Back of the Eye.- Development of Bile Acids as Anti-Apoptotic and Neuroprotective Agents in Treatment of Ocular Disease.
Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.
Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof.
Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms.
The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
Автор: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Автор: Shargel, Leon Название: Generic Drug Product Development ISBN: 0849377862 ISBN-13(EAN): 9780849377860 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Название: Generic drug product development ISBN: 036738437X ISBN-13(EAN): 9780367384371 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.
Автор: Kanfer, Isadore Название: Generic Drug Product Development ISBN: 0849377846 ISBN-13(EAN): 9780849377846 Издательство: Taylor&Francis Рейтинг: Цена: 26796.00 р. Наличие на складе: Поставка под заказ.
Автор: Shargel, Leon , Kanfer, Isadore Название: Generic Drug Product Development ISBN: 0367384396 ISBN-13(EAN): 9780367384395 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Поставка под заказ.
Описание:
Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives.
The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.
The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.
Описание: Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation.
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