International Pharmaceutical Product Registration, Cartwright, Anthony C.
Название: Pharmaceutical Drug Product Development and Process Optimization ISBN: 1771888725 ISBN-13(EAN): 9781771888721 Издательство: Taylor&Francis Рейтинг: Цена: 133730.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This volume presents and discusses the vital precepts underlying the efficient, effective, and cost-effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development.
Автор: Warne Название: Challenges in Protein Product Development ISBN: 3319906011 ISBN-13(EAN): 9783319906010 Издательство: Springer Рейтинг: Цена: 279500.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.
Автор: Nicholas W. Warne; Hanns-Christian Mahler Название: Challenges in Protein Product Development ISBN: 3030080528 ISBN-13(EAN): 9783030080525 Издательство: Springer Рейтинг: Цена: 279500.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.
Автор: Karen M. Nagel Название: Introduction to Biologic and Biosimilar Product Development and Analysis ISBN: 3030074927 ISBN-13(EAN): 9783030074920 Издательство: Springer Рейтинг: Цена: 102480.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Название: Pharmaceutical Product Development ISBN: 0367453177 ISBN-13(EAN): 9780367453176 Издательство: Taylor&Francis Рейтинг: Цена: 63280.00 T 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: Karen M. Nagel Название: Introduction to Biologic and Biosimilar Product Development and Analysis ISBN: 3319984276 ISBN-13(EAN): 9783319984278 Издательство: Springer Рейтинг: Цена: 83850.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Автор: Shargel, Leon , Kanfer, Isadore Название: Generic Drug Product Development ISBN: 0367384396 ISBN-13(EAN): 9780367384395 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Нет в наличии. 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.
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: 149060.00 T 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.
Название: Herbal Product Development ISBN: 1771888776 ISBN-13(EAN): 9781771888776 Издательство: Taylor&Francis Рейтинг: Цена: 133730.00 T Наличие на складе: Невозможна поставка. Описание: This new volume, Herbal Product Development: Formulation and Applications, addresses some of the challenges that hinder the path of successful natural products from laboratory to market.
Автор: Beg Sarwar Название: Design of Experiments for Pharmaceutical Product Development: Volume II: Applications and Practical Case Studies ISBN: 9813343508 ISBN-13(EAN): 9789813343504 Издательство: Springer Цена: 167700.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development.
Автор: Hickey Anthony J., Smyth Hugh D. C. Название: Pharmaco-Complexity: Non-Linear Phenomena and Drug Product Development ISBN: 303042782X ISBN-13(EAN): 9783030427825 Издательство: Springer Рейтинг: Цена: 46570.00 T Наличие на складе: Есть у поставщика Поставка под заказ. 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.
Автор: Beg Sarwar Название: Design of Experiments for Pharmaceutical Product Development: Volume I: Basics and Fundamental Principles ISBN: 9813347163 ISBN-13(EAN): 9789813347168 Издательство: Springer Цена: 158380.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development.
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