Описание: Containing four new chapters, along with several new and updated sections, this third edition reviews the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. It presents the current status of regulations on bioavailability and bioequivalence, including guidelines/guidances issued by the FDA, EMEA, and WHO. This edition addresses frequently asked questions and explores sample size determination, meta-analysis, and pharmacokinetics. It also offers a basic version of PharmaSoftware Solutions, Inc.’s BABE Solution 2008, with bioequivalence assessment for in vivo bioequivalence studies.
Автор: Niazi Sarfaraz K Название: Handbook Of Bioequivalence Testing ISBN: 0849303958 ISBN-13(EAN): 9780849303951 Издательство: Taylor&Francis Цена: 22968.00 р. Наличие на складе: Поставка под заказ.
Описание: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete and timely description of every aspect of bioequivalence testing, including worldwide regulatory requirements for filing for approval of generic drugs, applying for a waiver, securing regulatory approval of reports, and obtaining regulatory certification of facilities conducting bioequivalence studies.
Название: Generics and Bioequivalence ISBN: 0367208326 ISBN-13(EAN): 9780367208325 Издательство: Taylor&Francis Рейтинг: Цена: 7648.00 р. Наличие на складе: Поставка под заказ.
Описание: Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Practices.
Автор: Vinod P. Shah; Howard I. Maibach; John Jenner Название: Topical Drug Bioavailability, Bioequivalence, and Penetration ISBN: 1493938568 ISBN-13(EAN): 9781493938568 Издательство: Springer Рейтинг: Цена: 18284.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations.
Автор: Vinod P. Shah; Howard I. Maibach; John Jenner Название: Topical Drug Bioavailability, Bioequivalence, and Penetration ISBN: 1493912887 ISBN-13(EAN): 9781493912889 Издательство: Springer Рейтинг: Цена: 22359.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.
Release and Bioavailability of Nanoencapsulated Food Ingredients, volume five in the Nanoencapsulationin the Food Industry series, reviews different release mechanisms of nanoencapsulated food ingredients. The book discusses mathematical and intelligent modeling of the release of bioactive agents from nano-vehicles to better understand their release mechanisms, while also covering different approaches for studying the release profile of these ingredients (such as in-vitro and in-vivo assays). Authored by a team of global experts in the fields of nano and microencapsulation of food, nutraceutical and pharmaceutical ingredients, this title will be of great value to those engaged in various fields of nanoencapsulation.
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the
USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
Автор: Patterson Название: Bioequivalence and Statistics in Clinical Pharmacology ISBN: 1584885300 ISBN-13(EAN): 9781584885306 Издательство: Taylor&Francis Рейтинг: Цена: 13168.00 р. Наличие на складе: Поставка под заказ.
Описание: Bioequivalence and Statistics in Clinical Pharmacology covers the applications and basic elements of the theory of statistical methods in clinical pharmacology. It establishes techniques used in the assessment of bioequivalence and describes the use of statistics in clinical pharmacology studies of safety, ECG monitoring, efficacy, and population pharmacokinetics. The authors demonstrate study design, analysis, and interpretation of data using real data examples. The book emphasizes regulatory applications related to drug development and features a wide range of datasets as well as SAS and SPLUS code available on the Internet.
Автор: P. Baveye; J.-C. Block; V.V. Goncharuk Название: Bioavailability of Organic Xenobiotics in the Environment ISBN: 9048153115 ISBN-13(EAN): 9789048153114 Издательство: Springer Рейтинг: Цена: 41787.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Proceedings of the NATO Advanced Study Institute, held in Prague, Czech Republic from 18-29 August 1997
Автор: Lawrence X. Yu; Bing V. Li Название: FDA Bioequivalence Standards ISBN: 1493912518 ISBN-13(EAN): 9781493912513 Издательство: Springer Рейтинг: Цена: 25155.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: C Kies Название: Copper Bioavailability and Metabolism ISBN: 1461278554 ISBN-13(EAN): 9781461278559 Издательство: Springer Рейтинг: Цена: 16979.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: That less specific, less dramatic interactions among nutrients and among nutrients and other food components might enhance or inhibit the absorption of nutrients from the intestines or of the metabolism of nutrients within the body is an area of current concern.
Автор: Selim H. Magdi Название: Dynamics and Bioavailability of Heavy Metals in the Rootzone ISBN: 1439826226 ISBN-13(EAN): 9781439826225 Издательство: Taylor&Francis Рейтинг: Цена: 32155.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Concerns regarding heavy metal contamination in terrestrial ecosystems have prompted increasing efforts on limiting their bioavailability in the root zone. The complexity of the hydrologic system gives rise to the need for understanding the fate and transport of trace elements in the soil-water-plant environment. Dynamics and Bioavailability of Heavy Metals in the Rootzone provides a multidisciplinary approach with emphasis on geohydrology, plant and soil science, and environmental chemistry. The primary focus of this book is on different approaches that describe the dynamics of heavy metals in the soil system. These approaches are key to providing direct information on the concentration of heavy metals and hence on their transport, toxicity, and bioavailability.
The book includes chapters covering equilibrium and kinetic models of heavy metal interactions as well as non-equilibrium transport models. It also discusses chemical processes controlling soil solution concentrations and modeling of heavy metals adsorption. Addressing the biological component of heavy metal dynamics, this work examines rhizosphere microorganisms and phytoremediation. Colloid-associated transport, which can result in groundwater contamination, is discussed in relation to reclaimed mine sites. The authors also present an overview of recent advancements in the biogeochemistry of trace elements and their environmental implications. Additional chapters include examination of various natural environments including runoff waters at the watershed scale, heavy metal transformation in wetlands, dynamics of trace metals in frequently flooded soils, and effects on crops in biosolid-amended soils.
Reliable assessment of potential risks resulting from the transport of trace elements in the soil environment requires the examination of complex chemical and biological interactions due to the heterogeneous nature of soils. This text describes the current state of the art in this field and explores innovative experimental and theoretical/modeling approaches that will enhance this knowledge. The book provides a coherent presentation of recent advances in techniques, modeling, and dynamics and bioavailability of heavy metals in the root zone.
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