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.
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: 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.
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: Lawrence X. Yu; Bing V. Li Название: FDA Bioequivalence Standards ISBN: 1493955586 ISBN-13(EAN): 9781493955589 Издательство: Springer Рейтинг: Цена: 19564.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
.- 1 Bioequivalence History
.- Alex Yu, Duxin Sun, Bing Li, and Lawrence X. Yu
.- 2 Fundamentals of Bioequivalence
.- Mei-Ling Chen
.- 3 Basic Statistical Considerations
.- Fairouz T. Makhlouf, Stella C. Grosser, Donald J. Schuirmann
.- 4 The Effects of Food on Drug Bioavailability and Bioequivalence
.- Wayne I. DeHaven and Dale P. Conner
.- 5 Biowaiver and Biopharmaceutics Classification System
.- Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, and Lawrence X. Yu
.- 6 Bioequivalence of Highly Variable Drugs
.- Barbara M. Davit and Devvrat T. Patel
.- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments
.- Hao Zhu, Ramana Uppoor, Mehul Mehta, and Lawrence X. Yu
.- 8 Bioequivalence for Narrow Therapeutic Index Drugs
.- Nan Zheng, Wenlei Jiang, Robert Lionberger, and Lawrence X. Yu
.- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract
.- Xiaojian Jiang, Yongsheng Yang, and Ethan Stier
.- 13 Bioequivalence for Topical Drug Products
.- April C. Braddy and Dale P. Conner
.- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products
.- Bhawana Saluja, Bing V. Li and Sau L. Lee
.- 15 Bioequivalence: Modeling and Simulation
.- Xinyuan Zhang and Robert Lionberger
.- 16 Bioanalysis
.- Sriram Subramaniam.
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.
Название: Generics and Bioequivalence ISBN: 0367208318 ISBN-13(EAN): 9780367208318 Издательство: Taylor&Francis Рейтинг: Цена: 22968.00 р. Наличие на складе: Поставка под заказ.
Описание: For over five hundred years, Muslim dynasties ruled parts of northern and central India. Scholars have long drawn upon works written in Persian and Arabic about this epoch, yet they have neglected the many histories that India`s learned elite wrote about Indo-Muslim rule in Sanskrit. Audrey Truschke offers a groundbreaking analysis of these texts.
Explore the cutting-edge of dissolution testing in an authoritative, one-stop resource
In Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond, distinguished pharmaceutical advisor and consultant Dr. Umesh Banakar delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development.
After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle.
Over 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety.
This volume offers a one-stop resource for information otherwise scattered amongst several different regulatory regimes. It also includes:
A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing
Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence
Practical discussions about solubility, dissolution, permeability, and classification systems in drug development
In-depth examinations of the mechanics of dissolution, including mathematical models and simulations
An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications
A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products
Ideal for drug product development and formulation scientists, quality control and assurance professionals, and regulators, Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence is also the perfect resource for intellectual property assessors.
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.
Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions explains the role of alternative approaches to bioequivalence across various dosage forms, route of administration, and regulatory bodies with an ultimate aim of reducing clinical trial and bioequivalence study burdens. Sections focus on alternative bioequivalence approaches that can be fostered to minimize human testing, along with instigating new ideas and opening new avenues for the development of such approaches. It will be useful to pharmaceutical scientists working to produce affordable medicines to all as well as regulatory agencies, pharmaceutical companies, formulation scientists and clinical scientists.
This book covers several administration routes and deals with biowaivers for dosage form, routes of administration and geographical jurisdiction. Divided into five sections, including oral drug products, ophthalmic drug products, topical and transdermal drug products, orally inhaled and nasal drug products, and complex injectables, this book includes multiple real-world case studies alongside theory and protocols.
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