Genotoxic Impurities: Strategies for Identification and Control

Valutazione media 0
( su 0 valutazioni fornite da Goodreads )
 
9780470499191: Genotoxic Impurities: Strategies for Identification and Control

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.

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

From the Back Cover:

A one-stop reference to genotoxic impurities in pharmaceuticals

This volume examines the full range of issues the pharmaceutical industry faces when seeking to ensure control over the levels of genotoxic impurities in pharmaceuticals. It offers comprehensive practical guidance on how to both assess and control genotoxic impurities (GIs) through all phases of drug development.

Featuring contributed chapters by experts from both the quality assurance and toxicology fields, Genotoxic Impurities covers all topics from the ground up, using real-world examples and case studies to help readers meet the challenges of regulatory compliance. Other important features include:

  • A detailed review of current regulatory guidelines relating to GIs, including discussion of their implications and the thinking behind their development

  • A thorough evaluation of the threshold of toxicological concern (TTC) concept, along with an examination of the emerging evidence supporting the existence of thresholds even for DNA-reactive mutagens.

  • Step-by-step instructions , including both analytical and safety strategies, on how to evaluate risks posed by GIs

  • Discussion of the risks posed by GIs from other sources, i.e., dietary exposure and the endogenous production of genotoxins.

  • Specific advice on chromatographic strategy and other key analyticaltechniques, including the innovative use of NMR

The first comprehensive resource of its kind, Genotoxic Impurities is an indispensable reference for researchers and professionals in the pharmaceutical industry. It is also useful for regulatory professionals who need to interpret the regulatory guidelines covering GIs.

About the Author:

ANDREW TEASDALE, PhD, is a senior QA executive with AstraZeneca and chairs the company's internal genotoxic impurities advisory group. With over fifteen years of experience in analytical chemistry and quality assurance, Dr. Teasdale has published a number of papers relating to GIs and has been a speaker on genotoxic impurities at a number of conferences. Dr. Teasdale has also led two expert groups working in the field of genotoxic impurities, including an analytical group in the UK and a Project Quality Research Institute (PQRI) working group, which focused on the critical area of sulfonate ester formation and control.

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

I migliori risultati di ricerca su AbeBooks

1.

Editor-Andrew Teasdale
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Quantità: 2
Da
firstbookstore
(New Delhi, India)
Valutazione libreria
[?]

Descrizione libro Condizione libro: Brand New. Brand New Original US Edition, Perfect Condition. Printed in English. Excellent Quality, Service and customer satisfaction guaranteed!. Codice libro della libreria AIND-13769

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 104,28
Convertire valuta

Aggiungere al carrello

Spese di spedizione: GRATIS
Da: India a: U.S.A.
Destinazione, tempi e costi

2.

Editor-Andrew Teasdale
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Quantità: 2
Da
Bookshub
(Karol Bagh, India)
Valutazione libreria
[?]

Descrizione libro Condizione libro: New. New. US edition. Perfect condition. Customer satisfaction our priority. Codice libro della libreria ABE-FEB-45790

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 105,47
Convertire valuta

Aggiungere al carrello

Spese di spedizione: GRATIS
Da: India a: U.S.A.
Destinazione, tempi e costi

3.

Editor-Andrew Teasdale
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Quantità: 2
Da
EBOOKSTORE2010
(New Delhi, ND, India)
Valutazione libreria
[?]

Descrizione libro Condizione libro: Brand New. New. US edition. Customer Satisfaction guaranteed!!. Codice libro della libreria SHUB45790

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 105,52
Convertire valuta

Aggiungere al carrello

Spese di spedizione: GRATIS
Da: India a: U.S.A.
Destinazione, tempi e costi

4.

Editor-Andrew Teasdale
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Quantità: 2
Da
Romtrade Corp.
(STERLING HEIGHTS, MI, U.S.A.)
Valutazione libreria
[?]

Descrizione libro Condizione libro: New. Brand New Original US Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery. Codice libro della libreria AUSBNEW-13769

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 109,43
Convertire valuta

Aggiungere al carrello

Spese di spedizione: GRATIS
In U.S.A.
Destinazione, tempi e costi

5.

Editor-Andrew Teasdale
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Quantità: 2
Da
Basi6 International
(Irving, TX, U.S.A.)
Valutazione libreria
[?]

Descrizione libro Condizione libro: Brand New. New, US edition. Excellent Customer Service. Codice libro della libreria ABEUSA-45790

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 109,44
Convertire valuta

Aggiungere al carrello

Spese di spedizione: GRATIS
In U.S.A.
Destinazione, tempi e costi

6.

Editor: Andrew Teasdale
Editore: John Wiley and Sons
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Quantità: > 20
Da
INDOO
(Avenel, NJ, U.S.A.)
Valutazione libreria
[?]

Descrizione libro John Wiley and Sons. Condizione libro: New. Brand New. Codice libro della libreria 0470499192

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 107,54
Convertire valuta

Aggiungere al carrello

Spese di spedizione: EUR 3,04
In U.S.A.
Destinazione, tempi e costi

7.

Andrew Teasdale
Editore: Wileyand#8211;Blackwell (2011)
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Quantità: 4
Da
Books2Anywhere
(Fairford, GLOS, Regno Unito)
Valutazione libreria
[?]

Descrizione libro Wileyand#8211;Blackwell, 2011. HRD. Condizione libro: New. New Book. Shipped from UK in 4 to 14 days. Established seller since 2000. Codice libro della libreria FW-9780470499191

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 105,83
Convertire valuta

Aggiungere al carrello

Spese di spedizione: EUR 10,18
Da: Regno Unito a: U.S.A.
Destinazione, tempi e costi

8.

Editore: John Wiley and Sons Ltd, United States (2011)
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Rilegato Quantità: 1
Da
The Book Depository
(London, Regno Unito)
Valutazione libreria
[?]

Descrizione libro John Wiley and Sons Ltd, United States, 2011. Hardback. Condizione libro: New. New.. Language: English . Brand New Book. 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. Codice libro della libreria AAH9780470499191

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 116,29
Convertire valuta

Aggiungere al carrello

Spese di spedizione: GRATIS
Da: Regno Unito a: U.S.A.
Destinazione, tempi e costi

9.

Editore: John Wiley and Sons Ltd, United States (2011)
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Rilegato Quantità: 1
Da
The Book Depository US
(London, Regno Unito)
Valutazione libreria
[?]

Descrizione libro John Wiley and Sons Ltd, United States, 2011. Hardback. Condizione libro: New. New.. Language: English . Brand New Book. 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. Codice libro della libreria AAH9780470499191

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 116,66
Convertire valuta

Aggiungere al carrello

Spese di spedizione: GRATIS
Da: Regno Unito a: U.S.A.
Destinazione, tempi e costi

10.

Andrew Teasdale
Editore: John Wiley and Sons Ltd
ISBN 10: 0470499192 ISBN 13: 9780470499191
Nuovi Rilegato Quantità: 4
Da
THE SAINT BOOKSTORE
(Southport, Regno Unito)
Valutazione libreria
[?]

Descrizione libro John Wiley and Sons Ltd. Hardback. Condizione libro: new. BRAND NEW, Genotoxic Impurities: Strategies for Identification and Control, 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. Codice libro della libreria B9780470499191

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 124,36
Convertire valuta

Aggiungere al carrello

Spese di spedizione: EUR 7,86
Da: Regno Unito a: U.S.A.
Destinazione, tempi e costi

Vedi altre copie di questo libro

Vedi tutti i risultati per questo libro