This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment. Examines excipients as a unique class of products and explores new procedures for determining toxicity! A timely and unique addition to the pharmaceutical literature, containing over 570 citations that support and enhance the text, Excipient Toxicity and Safety · identifies the differences between excipients (inactive ingredients), food ingredients, and drug products · evaluates issues of dose administration, species selection, and study design for various routes of exposure · provides detailed information on the historical uses of excipients in drug formulations · clarifies the Safety Committee of the International Pharmaceutical Excipients Council's (IPEC) guidelines and technical specifications for conducting tests for each route of exposure · explains how data generated in toxicity models are applied to identify hazards in drug formulations · details exposure assessment to link hazard identification with risk · considers the requirements and importance of purity specifications · and much more! Excipient Toxicity and Safety is a blue-ribbon reference ideal for pharmacists; toxicologists; pharmacologists; analytical chemists; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.
Excipient Toxicity and Safety
and over one million other books are available for Amazon Kindle.
Learn more
FREE Two-Day Shipping for students on millions of items. Learn more |
| ||||||||||||||||||
Book Description
Product Details
Would you like to update product info or give feedback on images?
|
Customer Reviews
|
There are no customer reviews yet.
|
|||
|
Video reviews
|
Inside This Book
(learn more)
First Sentence:
There are several definitions for an excipient. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
new pharmaceutical excipient, test article application, reference listed drug, proposed drug product, human exposure pattern, toxicology testing program, excipient standards, new excipient, excipient monographs, liquid excipients, excipient manufacturers, biological reactivity tests, pharmaceutical excipients, comparative pharmacokinetic studies, phototoxicity testing, skin scoring, topical drug delivery systems, many excipients, skin flux, irritation evaluations, heavy metals test, organic volatile impurities, caudal thigh, developmental toxicity studies, sodium starch glycolate Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, New York, National Formulary, None None, Pharm Res, Pharmacopeial Forum, European Pharmacopoeia, Council Directive, Boca Raton, Pharm Sci, Federal Register, Marcel Dekker, European Union, Member States, International Conference, World Health Organization, Raven Press, Remington's Pharmaceutical Sciences, Commission of the European Communities, Fundam Appl Toxicol, Handbook of Pharmaceutical Excipients, Commission Decision, Handbook of Toxicology, Mack Publishing, Toxicol Appl Pharmacol New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
There are several definitions for an excipient. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
new pharmaceutical excipient, test article application, reference listed drug, proposed drug product, human exposure pattern, toxicology testing program, excipient standards, new excipient, excipient monographs, liquid excipients, excipient manufacturers, biological reactivity tests, pharmaceutical excipients, comparative pharmacokinetic studies, phototoxicity testing, skin scoring, topical drug delivery systems, many excipients, skin flux, irritation evaluations, heavy metals test, organic volatile impurities, caudal thigh, developmental toxicity studies, sodium starch glycolate Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, New York, National Formulary, None None, Pharm Res, Pharmacopeial Forum, European Pharmacopoeia, Council Directive, Boca Raton, Pharm Sci, Federal Register, Marcel Dekker, European Union, Member States, International Conference, World Health Organization, Raven Press, Remington's Pharmaceutical Sciences, Commission of the European Communities, Fundam Appl Toxicol, Handbook of Pharmaceutical Excipients, Commission Decision, Handbook of Toxicology, Mack Publishing, Toxicol Appl Pharmacol New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 100
books:
See all 100 books this book cites
- Principles and Methods of Toxicology by A Wallace Hayes on 6 pages
- Modern Pharmaceutics by Gilbert S. Banker on 4 pages
- Models in Dermatology (Models in Dermatology, 4) by Howard I. Maibach on 4 pages
- Dermal Absorption and Toxicity Assessment (Drugs and the Pharmaceutical Sciences) by Michael S. Roberts in Front Matter, page 181, and page 303
- Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control (Drugs and the Pharmaceutical Sciences Series, Vol 78) by Sidney H. Willig in Front Matter (1), Front Matter (2), and Front Matter (3)
See all 100 books this book cites
Books on Related Topics
(learn more)
|
Tag this product(What's this?)Think of a tag as a keyword or label you consider is strongly related to this product.
Tags will help all customers organize and find favorite items. |
Customer Discussions
|
This product's forum
Active discussions in related forums
Search Customer Discussions
|
Related forums
|
Listmania!
So You'd Like to...
Look for Similar Items by Category
- Books > Medical Books > Pharmacology > Pharmacy
- Books > Medical Books > Pharmacology > Toxicology
- Books > New & Used Textbooks > Medicine & Health Sciences > Allied Health Services > Pharmacy
- Books > New & Used Textbooks > Medicine & Health Sciences > Medicine > Basic Sciences > Pharmacology
- Books > New & Used Textbooks > Medicine & Health Sciences > Medicine > Basic Sciences > Toxicology
