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: Demetzos, Costas Название: Pharmaceutical Nanotechnology: Fundamentals and Practical Applications ISBN: 981100790X ISBN-13(EAN): 9789811007903 Издательство: Springer Рейтинг: Цена: 65210.00 T Наличие на складе: Невозможна поставка. Описание: This textbook explains the fundamental aspects of nanotechnology and fills the gap between bio-inspired nanotechnological systems and functionality of living organisms, introducing new insights to their physicochemical, biophysical and thermodynamic behaviour. Addressed to all those involved in recent advances in pharmaceutics, this book is divided in three major parts: Part A refers to the physicochemical and thermodynamics aspects of nanosystems, wherein their biophysical behaviour is correlated with that of the cells of living organisms; Part B refers to the application of nanotechnology in imaging, diagnostics and therapeutics; Part C is focused on issues regarding safety and nanotoxicity of nanosystems, and the regulatory framework that surrounds these. The text promotes the concept that biophysics, thermodynamics and nanotechnology are considered to be emerging tools that, when approached within regulatory boundaries, provide new and integrated knowledge for the production of new medicines. In 2018, Prof. Demetzos was honored with an award by the Order of Sciences of the Academy of Athens for his scientific contribution in Pharmaceutical Nanotechnology.
Название: Method Validation in Pharmaceutical Analysis: A Guide to Best Practice ISBN: 3527335633 ISBN-13(EAN): 9783527335633 Издательство: Wiley Рейтинг: Цена: 154120.00 T Наличие на складе: Невозможна поставка. Описание: The second edition of the best-selling practical guide to pharmaceutical analytics has been completely redesigned to take account of the Quality by Design (QbD) concept that has become the gold standard in pharmaceutical manufacturing. Two real-life case studies are included.
Название: Pharmaceutical Chemistry ISBN: 0199655308 ISBN-13(EAN): 9780199655304 Издательство: Oxford Academ Рейтинг: Цена: 35890.00 T Наличие на складе: Нет в наличии. Описание: Pharmaceutical Chemistry provides a wide-ranging overview of organic chemistry as applied to the study and practice of pharmacy. Drugs are simply chemicals, so to fully understand their manufacture, formulation, and the way they work in our bodies, an understanding of organic compounds and their reactions is essential.
Автор: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 183750.00 T 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.
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals
Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates--especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors--into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry.
This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book.
Topics covered include:
Drug Approval Process and Regulatory Requirements (private standards)
Pharmacopeias and Compendial Approval Process (public standards)
Common methods in pharmaceutical analysis (typically compendial)
Common Calculations for assays and impurities and other specific tests
Analytical Method Validation, Verification, Transfer
Specifications including how to handle out of specification (OOS) and out of trend (OOT)
Impurities including organic, inorganic, residual solvents and elemental impurities
Good Documentation Practices for regulatory environment
Management of Analytical Laboratories
Analytical Instrument Qualifications including IQ, OQ, PQ and VQ
Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted.
Pharmaceutical Analysis for SmallMolecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
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