10% endirim hədiyyə edin
Bu kitabı tövsiyə edin və dostunuzun alışından 28,18 ₼ əldə edin.
0+
mətnPDF
Həcm 701 səhifə
Leachables and Extractables Handbook
Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
mətnPDF
281,78 ₼
Kitab haqqında
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug productsPackaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)—such as metered dose inhalers, dry powder inhalers, and nasal sprays—pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as:Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug productsPrinciples for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug productsRegulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocolsAnalytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
Janr və etiketlər
Rəy bildirmək
Giriş, kitabı qiymətləndirmək və rəy bildirmək
Kitabın təsviri
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products
Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)—such as metered dose inhalers, dry powder inhalers, and nasal sprays—pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as:
Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products
Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products
Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols
Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
Kitab «Leachables and Extractables Handbook» — saytda onlayn oxuyun. Şərh və rəylərinizi qeyd edin, sevimlilərinizi seçin.
Yaş həddi:
0+Litresdə buraxılış tarixi:
28 sentyabr 2018Həcm:
701 səh. ISBN:
9781118147702Ümumi ölçü:
16 МБSəhifələrin ümumi sayı:
701Naşir:
Müəllif hüququ sahibi:
John Wiley & Sons Limited
