عرض عادي
Combination products : regulatory challenges and successful product developement / Smita Gopalaswamy, Venky Gopalaswamy.
نوع المادة :
نصالناشر:Boca Raton : CRC Press, [2008]تاريخ حقوق النشر: ©2008وصف:xvi, 241 pages : illustrations ; 25 cmنوع المحتوى:- text
- unmediated
- volume
- 9781420064469 (hardcover : alk. paper)
- 1420064460 (hardcover : alk. paper)
- Drugs -- Standards -- United States
- Medical instruments and apparatus -- Standards -- United States
- Biological products -- Standards -- United States
- United States. Food and Drug Administration
- United States. Food and Drug Administration
- Equipment Design -- standards -- United States
- Pharmaceutical Preparations -- standards -- United States
- Biological Products -- standards -- United States
- Device Approval -- standards -- United States
- Equipment and Supplies -- standards -- United States
- RM301.27 .G68 2008
المحتويات:
Overview of combination products -- Ensuring successful combination product development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Postlaunch compliance requirements -- Agency audits and challenges.
| نوع المادة | المكتبة الحالية | رقم الطلب | رقم النسخة | حالة | تاريخ الإستحقاق | الباركود | |
|---|---|---|---|---|---|---|---|
كتاب
|
UAE Federation Library | مكتبة اتحاد الإمارات General Collection | المجموعات العامة | RM301.27 .G68 2008 (إستعراض الرف(يفتح أدناه)) | C.1 | Library Use Only | داخل المكتبة فقط | 30020000010315 | ||
|
كتاب
|
UAE Federation Library | مكتبة اتحاد الإمارات General Collection | المجموعات العامة | RM301.27 .G68 2008 (إستعراض الرف(يفتح أدناه)) | C.2 | المتاح | 30020000012232 | ||
|
كتاب
|
UAE Federation Library | مكتبة اتحاد الإمارات General Collection | المجموعات العامة | RM301.27 .G68 2008 (إستعراض الرف(يفتح أدناه)) | C.3 | المتاح | 30020000012231 |
Includes bibliographical references and index.
Overview of combination products -- Ensuring successful combination product development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Postlaunch compliance requirements -- Agency audits and challenges.
