Development and Approval of Combination Products

افزودن به بوکمارک اشتراک گذاری 0 دیدگاه کاربران 5 (0)

A Regulatory Perspective

مشارکت: عنوان و توضیح کوتاه هر کتاب را ترجمه کنید این ترجمه بعد از تایید با نام شما در سایت نمایش داده خواهد شد.

ترجمه این کتاب مشاهده همه کتاب های ترجمه نشده

A Regulatory Perspective

A step-by-step, integrated approach for successful, FDA-approved combination drug products

Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval.

The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are:
* The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products
* Approaches to clinical trial protocol design and execution
* Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products
* Key sponsor/FDA meetings and negotiations essential for approval and commercialization

Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes.

This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.

لغو

گزارش تخلف

مغایرت عنوان کتاب با توضیحات و تصویر جلد
عدم رعایت حقوق نشر طبق قوانین جمهوری اسلامی ایران
محتوای مستهجن
توهین به قومیتها و محتوای نژادپرستی
توهین به اقیلیتهای مذهبی
اهانت به مقامات سیاسی و مذهبی
اشاعه ی کودک آزاری
سایر موارد

بستن

فرمت کتاب

ebook

زبان

english

تاریخ انتشار

2008

نویسنده

Evan B. Siegel

ناشر

Wiley-Interscience

شابک

9780470050941

20,000 تومان

خرید کتاب مطالعه نمونه درخواست ترجمه کتاب

خرید کتاب Development and Approval of Combination Products

Development and Approval of Combination Products

گزارش تخلف

فرمت کتاب

ebook

زبان

english

تاریخ انتشار

2008

نویسنده

ناشر

شابک

کتاب های مرتبط

Animal cell technology : developments, processes, and products

200 Tips, Techniques, and Recipes for Natural Beauty

Bioactive compounds from terrestrial extremophiles

Herb Toxicities & Drug Interactions : A Formula Approach.

Human Health and Forests

A secret world : natural products of marine life

Plant Bioproducts

Biosimilars

Biosynthesis and Molecular Genetics of Fungal Secondary Metabolites

Encyclopedia of Marine Natural Products

Natural Products

Biotherapy - history, principles and practice : a practical guide to the diagnosis and treatment of disease using living organisms

Natural Products in Cancer Prevention and Therapy

Natural products in cancer prevention and therapy

Development and Approval of Combination Products

Food and Industrial Bioproducts and Bioprocessing

Bioproducts from Canada's Forests

Manipulating Theophany

Biodiversity and Biomedicine

Lyophilization of Pharmaceuticals and Biologicals

Pharmaceuticals from microbes : the bioengineering perspective

دیدگاه کاربران