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: Alessandrini, Donatella (university Of Kent, Uk) Название: Value making in international economic law and regulation ISBN: 1138565490 ISBN-13(EAN): 9781138565494 Издательство: Taylor&Francis Рейтинг: Цена: 51030.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book examines the contemporary production of economic value in today`s financial economies. Examining current projects of international legal regulation, this book questions the regulation of the financial sphere insofar as its excesses are juxtaposed to some notion of economic normality.
Автор: Brady John E., Brady Amy J. Название: Regulation: Audit, Inspection, Standards and Risk: A Handbook for Street-Level Regulators ISBN: 0993082238 ISBN-13(EAN): 9780993082238 Издательство: Неизвестно Цена: 22980.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The book brings together Inspection skills for frontline staff. It is a coherent framework of practice, theory, ethics and competency drawing on academic and professional sources. It contains comprehensive sections on Risk, Standards, Planning, Inspection and Improvement. The book provides a step-by-step guide through an inspection or audit using the model 'Plan, Inspect and Improve', stages designed to identify problems and to promote improvement. Authoritative and fully referenced, it is approximately 42000 words and available in paperback and e-book.'A splendid contribution', John Braithwaite, Australian National University. 'It is a very useful and distinctive contribution to the literature on regulation, a hands-on approach that will be of considerable value to front-line regulators' Neil Gunningham, Australian National University
Автор: Golombok Название: Regulating Reproductive Donation ISBN: 1107090962 ISBN-13(EAN): 9781107090965 Издательство: Cambridge Academ Рейтинг: Цена: 81310.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The emergence of new empirical evidence and ethical debate has called into question the current regulatory frameworks that govern reproductive donation, both in the UK and overseas. In response, this book offers fresh interdisciplinary perspectives on current challenges facing the regulation of reproductive donation, and suggests possible ways forward.
Автор: Cary Coglianese Название: Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation ISBN: 0812244605 ISBN-13(EAN): 9780812244601 Издательство: Wiley EDC Рейтинг: Цена: 66350.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation brings fresh insight and analytic rigor to what has become one of the most contested domains of American domestic politics. Critics from the left blame lax regulation for the housing meltdown and financial crisis—not to mention major public health disasters ranging from the Gulf Coast oil spill to the Upper Big Branch Mine explosion. At the same time, critics on the right disparage an excessively strict and costly regulatory system for hampering economic recovery. With such polarized accounts of regulation and its performance, the nation needs now more than ever the kind of dispassionate, rigorous scholarship found in this book. With chapters written by some of the nation's foremost economists, political scientists, and legal scholars, Regulatory Breakdown brings clarity to the heated debate over regulation by dissecting the disparate causes of the current crisis as well as analyzing promising solutions to what ails the U.S. regulatory system. This volume shows policymakers, researchers, and the public why they need to question conventional wisdom about regulation—whether from the left or the right—and demonstrates the value of undertaking systematic analysis before adopting policy reforms in the wake of disaster.
Автор: Justin O`Brien Название: The Triumph, Tragedy and Lost Legacy of James M Landis: A Life on Fire ISBN: 1849466173 ISBN-13(EAN): 9781849466172 Издательство: Bloomsbury Academic Рейтинг: Цена: 73920.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: James M Landis is known for his seminal contribution to the creation of the modern system of market regulation in the USA. This book explains for the first time how and why, shortly before his early death, Landis abandoned his theory of market regulation.
Автор: Christopher Hodges Название: Law and Corporate Behaviour: Integrating Theories of Regulation, Enforcement, Compliance and Ethics ISBN: 184946653X ISBN-13(EAN): 9781849466530 Издательство: Bloomsbury Academic Рейтинг: Цена: 137280.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The purpose of this book is to examine the theories and practice of how to control corporate behaviour through legal techniques.
Автор: Lindsay Lockwood, Paul Garritano Название: State Regulation of Small Business: Impact of Regulatory Flexibility ISBN: 1629481939 ISBN-13(EAN): 9781629481937 Издательство: Nova Science Рейтинг: Цена: 196410.00 T Наличие на складе: Невозможна поставка. Описание: The Regulatory Flexibility Act of 1980 established a process of analysing and mitigating impacts of federal regulations on small businesses and other small entities. In the ensuing years, states began adopting regulatory flexibility legislation (or executive orders) of their own. In 2002 the SBA Office of Advocacy launched a Model Legislation Initiative utilising a model state regulatory flexibility bill, which incorporated many elements of the federal legislation in simplified form. The model legislation was published for general use in 2005, along with supporting commentary and materials, and a guidance document to assist states in implementing regulatory flexibility legislation was published in 2007. About half the states adopted regulatory flexibility legislation in the period 2002-2007. By the end of this period, the SBA data showed that 45 states and territories had some form of regulatory flexibility legislation or executive order, and about 20 of those included all of the elements in the model legislation. SBAs Model Legislation Initiative wound down at the end of the Bush administration, although progress continued at the state level. This book examines regulatory flexibility at the state level with two general purposes: to assess the implementation of state regulatory flexibility laws; and to document further developments of state regulatory flexibility programs. The book draws on available public documents and examines the legislation of each state and traces the rule-making process from notice through regulatory flexibility analysis and review.
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