عنوان
پدید آورنده
موضوع
رده
RS200
RS200
کتابخانه
محل استقرار
شابک
شابک
1118147677 (electronic bk.)
شابک
1118147707 (electronic bk.)
شابک
9781118147672 (electronic bk.)
شابک
9781118147702 (electronic bk.)
شابک اشتباه
0470173653
شابک اشتباه
9780470173657
شماره کتابشناسی ملی
شماره
dltt
عنوان و نام پديدآور
عنوان اصلي
Leachables and Extractables Handbook :
نام عام مواد
[Book]
ساير اطلاعات عنواني
Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products.
مشخصات ظاهری
نام خاص و کميت اثر
1 online resource (701 pages)
يادداشت کلی
متن يادداشت
Appendix 4: protocol addition, phase 2 studies: quantitative extractables studies on sulfur-cured elastomer and polypropylene
متن يادداشت
Description based upon print version of record
یادداشتهای مربوط به مندرجات
متن يادداشت
Leachables and extractables handbook; robert kroes: in memoriam; contents; preface; acknowledgments; contributors; part i: development of safety thresholds, safety evaluation, and qualification of extractables and leachables in orally inhaled and nasal drug products; chapter 1: overview of leachables and extractables in orally inhaled and nasal drug products; chapter 2: a general overview of the suitability for intended use requirements for materials used in pharmaceutical systems; chapter 3: concept and application of safety thresholds in drug development
متن يادداشت
Chapter 12: pharmaceutical container closure systems: selection and qualification of materialschapter 13: analytical techniques for identification and quantitation of extractables and leachables; chapter 14: extractables: the controlled extraction study; chapter 15: extractables: case study of a sulfur-cured elastomer; chapter 16: case study of a polypropylene: extractables characterization, quantitation, and control; chapter 17: analytical leachables studies; chapter 18: development, optimization, and validation of methods for routine testing
متن يادداشت
Chapter 19: critical component quality control and specification strategieschapter 20: inorganic leachables; chapter 21: foreign particulate matter: characterization and control in a quality-by-design environment; appendixes; appendix 1: experimental protocol for controlled extraction studies on elastomeric test articles; appendix 2: experimental protocol for controlled extraction studies on plastic test articles; appendix 3: protocol addition, phase 2 studies: quantitative controlled extraction studies on the sulfur-cured elastomer
متن يادداشت
Chapter 4: the development of safety thresholds for leachables in orally inhaled and nasal drug productschapter 5: the analytical evaluation threshold (aet) and its relationship to safety thresholds; chapter 6: safety thresholds in the pharmaceutical development process for oindp: an industry perspective; chapter 7: the chemistry and toxicology partnership: extractables and leachables information sharing among the chemists and toxicologists; chapter 8: use of safety thresholds in the pharmaceutical development process for oindp: u.s. regulatory perspectives
متن يادداشت
Chapter 9: the application of the safety thresholds to qualify leachables from plastic container closure systems intended for pharmaceutical products: a regulatory perspectivepart ii: best practices for evaluation and management of extractables and leachables in orally inhaled and nasal drug products; chapter 10: analytical best practices for the evaluation and management of extractables and leachables in orally inhaled and nasal drug products; chapter 11: chemical and physical attributes of plastics and elastomers: impact on the extractables profile of container closure systems
بدون عنوان
0
بدون عنوان
8
بدون عنوان
8
بدون عنوان
8
بدون عنوان
8
یادداشتهای مربوط به خلاصه یا چکیده
متن يادداشت
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 extrac
یادداشتهای مربوط به سفارشات
منبع سفارش / آدرس اشتراک
Wiley InterScience
شماره انبار
10.1002/9781118147672
ویراست دیگر از اثر در قالب دیگر رسانه
عنوان
Leachables and Extractables Handbook : Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
شماره استاندارد بين المللي کتاب و موسيقي
9780470173657
موضوع (اسم عام یاعبارت اسمی عام)
موضوع مستند نشده
Drug delivery systems-- Safety measures.
موضوع مستند نشده
Drug stability.
موضوع مستند نشده
Drugs-- Dosage forms.
موضوع مستند نشده
Leachate-- Health aspects.
موضوع مستند نشده
Pharmaceutical industry-- Quality control.
موضوع مستند نشده
Pharmaceutical policy.
موضوع مستند نشده
Pharmaceutical technology-- Quality control.
مقوله موضوعی
موضوع مستند نشده
MED-- 071000
رده بندی ديویی
شماره
615/
.
6
رده بندی کنگره
شماره رده
RS200
نام شخص به منزله سر شناسه - (مسئولیت معنوی درجه اول )
مستند نام اشخاص تاييد نشده
Ball, Douglas J.
نام شخص - (مسئولیت معنوی برابر )
مستند نام اشخاص تاييد نشده
Nagao, Lee.
مستند نام اشخاص تاييد نشده
Norwood, Daniel L.
مستند نام اشخاص تاييد نشده
Stults, Cheryl L.
نام تنالگان _ (مسئولیت معنوی برابر)
مستند نام تنالگان تاييد نشده
Ohio Library and Information Network.
مستند نام تنالگان تاييد نشده
Wiley Online Library (Online service)
مبدا اصلی
تاريخ عمليات
20130111115408.0
قواعد فهرست نويسي ( بخش توصيفي )
rda
دسترسی و محل الکترونیکی
نام الکترونيکي
مطالعه متن کتاب اطلاعات رکورد کتابشناسی
نوع ماده
[Book]
اطلاعات دسترسی رکورد
تكميل شده
Y
