Author: Meredith Brown-Tuttle
Edition: 1st
Binding: Ring-bound
ISBN: 0578007002
Edition: 1st
Binding: Ring-bound
ISBN: 0578007002
IND Submissions: A Primer
IND Submissions: A Primer provides a hands-on approach that teaches regulatory professionals novice and veteran alike to work with the regulations, guidance documents, content templates, contributing authors, and style guides necessary to write an IND. The book s writing tips show regulatory professionals how to produce a range of U.S. drug and biologics submissions that comply with the requirements and are also clear to read. Included with the book is a CD filled with electronic examples. IND Submissions: A Primer is the only comprehensive IND manual of its kind. This 600-page, spiral-bound, hardcover book is easy to use, providing step-by-step instructions on how to plan, write, and submit regulatory documents. Each chapter (62 in total) is "This comprehensive guide presents the principles underlying the formation, properties and manufacturing of solid dosage forms. Developed by a leading pharmaceutical expert with 25 years of experience, this book is a precise handbook to powder dosage forms, hard shell capsules, milling, tablet, granulation and drying, stability, crystalline solids, DSC and amorphates, hygroscopicity, packaging, micromeritics, sustained release, and more. Designed for use by development pharmacists, analytical chemists, production pharmacists, and pharmacy professors and students, this book emphasizes US validation principles; the interrelationship between formulation, manufacturing and existing USP and FDA guidelines; and aspects of pharmaceutics important to IND and NDA submission and subsequent supplements.File Size: 5402 KBPrint Length: 259 pagesPublisher: CRC Press; 1 edition (August 16, 1993) Sold by: Amazon Digital Services, Inc.Language: EnglishASIN: B0084FA7EW" Read medical textbooks online like IND Submissions here
Ind Submissions: A Primer
New Ring-bound.
Submission Revealed ISBN :9781419959059 Title :Submission Revealed Authors :Hunter, Diana Binding :Paperback Publisher :Ellora''''s Cave Publication Date :May 30 2009 Edition : Condition :Used - Acceptable Comments :A readable copy. About Goodwill of Central Florida Our company is dedicated to providing you with the best quality, lowest cost products on eBay. The proceeds from our ebay sales help fund our mission of assisting people with disabilities and other barriers to employment to live ind
Store Search search Title, ISBN and Author Antibiotic Discovery and Development Estimated delivery 3-12 business days Format Hardcover Condition Brand New With plenty of full-color illustrations, up-to-date research and expert authors, this handbook covers every aspect of the discovery and development process relating to antibiotics through Phase II and III, including chapters on preparing for IND submission. Publisher Description This volume covers all aspects of the antibiotic discovery and d
This volume covers all aspects of the antibiotic discovery and development process through Phase II/III. The contributors, a group of highly experienced individuals in both academics and industry, include chapters on the need for new antibiotic compounds, strategies for screening for new antibiotics, sources of novel synthetic and natural antibiotics, discovery phases of lead development and optimization, and candidate compound nominations into development. Beyond discovery , the handbook will cover all of the studies to prepare for IND submission: Phase I (safety and dose ranging), progressio
IND Submissions Online
The book s writing tips show regulatory professionals how to produce a range of U.S. drug and biologics submissions that comply with the requirements and are also clear to read. Included with the book is a CD filled with electronic examples
Each chapter (62 in total) is
