Pharmaceutical Industry Practices on Genotoxic Impurities
Fr. 303.00
inkl. gesetzl. MwSt.,
Beschreibung
Produktdetails
Einband
Gebundene Ausgabe
Erscheinungsdatum
04.09.2014
Abbildungen
schwarz-weiss Illustrationen, Tabellen, schwarz-weiss
Herausgeber
Heewon LeeVerlag
Taylor & FrancisSeitenzahl
536
Maße (L/B/H)
23.4/15.5/3.3 cm
Gewicht
885 g
Sprache
Englisch
ISBN
978-1-4398-7420-2
"Preface According to the World Health Organization's International Agency for Research on Cancer (IARC) (Technical Publication No. 24, 1994), genotoxicity is defined as structural changes at the level of a gene. It is also defined as a broad term that refers to any deleterious change in the genetic material regardless of the mechanism by which the change is induced, as stated by ICH S2(R1), "Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use." Genotoxic compounds have the theoretical potential to damage DNA at any level of exposure, leading to tumor development. This makes the toxicological assessment and determination of acceptable limits of genotoxic impurities (GTIs) difficult. GTIs have become an intensely debated topic in the pharmaceutical industry in recent years. My experiences in the internal and external discussions in meetings and conferences indicate that there is a great deal of confusion and uncertainty over identification, assessment, and control of GTIs. GTIs require different rationale and strategies from "regular" or "ordinary" impurities. Proper management of GTIs entails appropriate guidance and strategies, effective communication between various disciplines, sharing information and results, and understanding of the overall implications. The goal of this book is to present the rationale, strategies, methods, interpretation, practices, and case studies in the pharmaceutical industry in order to facilitate scientific and systematic consensus establishment on GTIs"--
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