Эта книга исследует генотоксичные примеси и их влияние на фармацевтическую промышленность. В ней рассматриваются стратегии идентификации и контроля таких примесей с токсикологической и аналитической точек зрения. В начальном разделе освещается разработка рекомендаций и порогового уровня токсикологической значимости (TTC), за которым следует раздел о безопасности, включающий описание тестов на безопасность in vivo и in vitro и интерпретацию данных. Во втором разделе речь идет о рисках, связанных с генотоксичными примесями из внешних источников и мутагенами внутри ДНК. В заключительном разделе с качественной точки зрения рассматриваются два критически важных аспекта генотоксичных примесей: анализ и практическая оценка таких примесей.
In this book, Teasdale discusses genotoxic impurities – how they can do harm to people, particularly to those who need drug treatment, in order to raise awareness by pharmaceutical companies about the importance of checking for these dangerous poisons minute by minute. There are individual sections that explore the ins and outs of the subject – from a toxicology perspective and then from an analytical one.
This includes the imparting of proper strategies – measures used by healthcare providers when attempting to assess and eventually eliminate genotoxic substances threateningly present within drugs, so we can better understand the control mechanisms integral to the process. Aside from mere guidelines, there are also sections on the safety topics that encompass analytical interpretation, then discussing how foreign stimuli and compounds within DNA pose a potential threat, while rounds back to providing insights regarding the quality-centric fashion of treating these toxins, covering specific metrics for analysing them and devising practical evaluation methods.
Электронная Книга «Genotoxic Impurities. Strategies for Identification and Control» написана автором Andrew Teasdale в году.
Минимальный возраст читателя: 0
Язык: Английский
ISBN: 9780470929360
Описание книги от Andrew Teasdale
This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.
