Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals
DOWNLOAD
Download Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals
DOWNLOAD
Author : Satinder Ahuja
language : en
Publisher: Academic Press
Release Date : 2003-07-18
Handbook Of Isolation And Characterization Of Impurities In Pharmaceuticals written by Satinder Ahuja and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-07-18 with Medical categories.
The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
Handbook Of Modern Pharmaceutical Analysis
DOWNLOAD
Author : Satinder Ahuja
language : en
Publisher: Academic Press
Release Date : 2010-11-11
Handbook Of Modern Pharmaceutical Analysis written by Satinder Ahuja and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-11-11 with Medical categories.
Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS
Pharmaceutical Stress Testing
DOWNLOAD
Author : Steven W. Baertschi
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Pharmaceutical Stress Testing written by Steven W. Baertschi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability
Characterization Of Impurities And Degradants Using Mass Spectrometry
DOWNLOAD
Author : Guodong Chen
language : en
Publisher: John Wiley & Sons
Release Date : 2011-04-27
Characterization Of Impurities And Degradants Using Mass Spectrometry written by Guodong Chen and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-27 with Science categories.
The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.
Handbook Of Trace Analysis
DOWNLOAD
Author : Irena Baranowska
language : en
Publisher: Springer
Release Date : 2015-08-13
Handbook Of Trace Analysis written by Irena Baranowska and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-13 with Science categories.
This handbook is unique in its comprehensive coverage of the subject and focus on practical applications in diverse fields. It includes methods for sample preparation, the role of certified reference materials, calibration methods and statistical evaluation of the results. Problems concerning inorganic and bioinorganic speciation analysis, as well as special aspects such as trace analysis of noble metals, radionuclides and volatile organic compounds are also discussed. A significant part of the content presents applications of methods and procedures in medicine (metabolomics and therapeutic drug monitoring); pharmacy (the analysis of contaminants in drugs); studies of environmental samples; food samples and forensic analytics – essential examples that will also facilitate problem solving in related areas.
Pharmaceutical Analysis For Small Molecules
DOWNLOAD
Author : Behnam Davani
language : en
Publisher: John Wiley & Sons
Release Date : 2017-08-01
Pharmaceutical Analysis For Small Molecules written by Behnam Davani and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-01 with Science categories.
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 Small Molecules 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.
Pharmaceutical Analysis For Small Molecules
DOWNLOAD
Author : Behnam Davani
language : en
Publisher: John Wiley & Sons
Release Date : 2017-08-14
Pharmaceutical Analysis For Small Molecules written by Behnam Davani and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-14 with Science categories.
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 Small Molecules 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.
Handbook Of Pharmaceutical Granulation Technology
DOWNLOAD
Author : Dilip M. Parikh
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Handbook Of Pharmaceutical Granulation Technology written by Dilip M. Parikh and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re
Analysis Of Drug Impurities
DOWNLOAD
Author : Richard J. Smith
language : en
Publisher: John Wiley & Sons
Release Date : 2008-04-15
Analysis Of Drug Impurities written by Richard J. Smith and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-04-15 with Science categories.
A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the analytical chemist. Analytical science is developing rapidly and provides increasing opportunity to identify the structure, and therefore the origin and safety implications of these impurities, and the challenges of their measurement drives the development of modern quantitative methods. Written for both practicing and student analytical chemists, Analysis of Drug Impurities provides a detailed overview of the challenges and the techniques available to permit accurate identification and quantification of drug impurities.
Insight On Genotoxicity
DOWNLOAD
Author : Shiv Shankar Shukla
language : en
Publisher: CRC Press
Release Date : 2020-10-14
Insight On Genotoxicity written by Shiv Shankar Shukla and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-10-14 with Science categories.
Genetic toxicology is considered to be an important assessment tool as there is genetic impact of artificial chemicals. Insight on Genotoxicity discusses testing, mechanism, prediction, and bioindicator of genotoxicity taking into consideration recent advances in nano-engineered particles. Corollary of DNA dent is also discussed in detail taking into consideration the impact of ICH guidelines on genotoxicity testing, which is important for drug discovery innovation and development. Perspective review of genotoxicity evaluation in phytopharmaceuticals has been mentioned along with the prevention of genotoxicity in brief viewpoint. Salient Features Presents methods, standard protocols, and guidelines for genotoxicity testing Examines the impact of ICH Guidelines on genetic toxicity testing which is a regulatory requirement for drug discovery and development Defines appropriate strategies about advances in in vivo genotoxicity testing which have been listed along with progress and prospects Discusses advancement in the high-throughput approaches for genotoxicity testing Details computational prediction of genotoxicity with consideration of mutagenicity, chromosomal damage caused and strategies for computational prediction in drug development