The Science and Regulations of Naturally Derived Complex Drugs

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

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

از خودتان درباره کتاب توضیح کوتاهی بنویسید

This volume in the AAPS Advances series covers various quality, safety (immunogenicity) and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific areas discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products, The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.

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

2019

نویسنده

Larry A Walker

ناشر

Springer

شابک

9783030117504;9783030117511

20,000 تومان

خرید کتاب مطالعه نمونه درخواست ترجمه کتاب

خرید کتاب The Science and Regulations of Naturally Derived Complex Drugs

The Science and Regulations of Naturally Derived Complex Drugs

گزارش تخلف

فرمت کتاب

ebook

زبان

english

تاریخ انتشار

2019

نویسنده

ناشر

شابک

کتاب های مرتبط

Antibody-Drug Conjugates : the 21st Century Magic Bullets for Cancer

Pediatric Formulations

FDA Bioequivalence Standards

Applied Pharmacometrics

Hydrophilic Matrix Tablets for Oral Controlled Release

Pharma-Nutrition

Clinical trial simulations : applications and trends

Formulating poorly water soluble drugs

Mucosal Delivery of Drugs and Biologics in Nanoparticles

Continuous Pharmaceutical Processing

The Role of Microstructure in Topical Drug Product Development (AAPS Advances in the Pharmaceutical Sciences Series)

The Science and Regulations of Naturally Derived Complex Drugs

Challenges in Protein Product Development

3D Printing of Pharmaceuticals (AAPS Advances in the Pharmaceutical Sciences Series (31))

Biosimilars

Non-Biological Complex Drugs

Antibody-Drug Conjugates

Bioequivalence Requirements in Various Global Jurisdictions

Targeted Intracellular Drug Delivery by Receptor Mediated Endocytosis

Pharma-nutrition : an overview

Formulating Poorly Water Soluble Drugs

دیدگاه کاربران