Expediting Biologics x185

SEARCH
Publications

Expediting Drug and Biologics Development: A Strategic Approach 2006

- $145.00

Using a unique "reverse-engineering" approach, dozens of leading experts with extensive experience in all disciplines of drug and biologic development show how careful planning and a sharp focus on the end-goals can be used to expedite even the most complex product development programs today!

From the first preclinical testing to clinical trials to the NDA/BLA review, Expediting Drug and Biologics Development shows you how to use reverse-engineering techniques to drive and improve each aspect of a development program's design and implementation.

The new third edition of Expediting Drug and Biologics Development is not a summary of U.S. or international regulatory requirements. Rather, it is a real-world "doer's" guide to drug and biologics development. It provides dozens of templates, forms, and tools to assists those "in the trenches" of new drug and biologic development today.

With this book, you will learn how to: 

  • apply the very latest and most advanced project management techniques directly to challenges presented by the drug development process.

  • critically evaluate the needs of the package insert and marketing application up front, before getting deeply into clinical trials.

  • leverage standardization to drive and expedite the entire development process, from the development of clinical trial protocols to the development of clinical data presentations.

  • critically assess the needs of the final report before developing the clinical protocol.

  • use draft case report forms (CRF) to dictate the content of the procedures section of the clinical protocol.

  • constructively consider the methods for data analysis in developing the clinical protocol.

In addition, Expediting Drug and Biologics Development 2006 will provide you with direct access to the expertise and recommendations of dozens of the most experienced and forward-thinking experts in the pharmaceutical and biotechnology industries today.

February 2006, 340 pp., ISBN# 1-882615-76-X, $145.00
Edited by Steven E. Linberg, Ph.D., Chiesi Pharmaceuticals




FOLLOW US ON: 

LinkedIn twitter Facebook 


On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

Jan - July 2014 Edition

Winter CatalogDownload Today!  

Blended Curriculum Path for the CRA, CRC, and Project Manager

BCP Cover

Download Today! 

 

 

 


 

DVD IconWEB SEMINAR ARCHIVE 

 View Catalog of Offerings   

New Titles added every month! 
Course Alumni Save 50% 


Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)