New drug development: A regulatory overview

2.67 avg rating
( 3 ratings by Goodreads )
 
9781882615551: New drug development: A regulatory overview
View all copies of this ISBN edition:
 
 

Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including:

* How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements.

* How the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes.

* How CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process.

* How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions.

* Which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process.


Find out why New Drug Development is pharma/biotech's go-to resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes.

"synopsis" may belong to another edition of this title.

Top Search Results from the AbeBooks Marketplace

1.

Mathieu, Mark P; Mathieu, Mark
Published by PAREXEL International Corp
ISBN 10: 1882615557 ISBN 13: 9781882615551
Used PAPERBACK Quantity Available: 1
Seller:
Hawking Books
(Lake Arrowhead, CA, U.S.A.)
Rating
[?]

Book Description PAREXEL International Corp. PAPERBACK. Condition: Very Good. 1882615557 Very Good Condition. Five star seller - Buy with confidence!. Seller Inventory # Z1882615557Z2

More information about this seller | Contact this seller

Buy Used
US$ 5.69
Convert currency

Add to Basket

Shipping: FREE
Within U.S.A.
Destination, rates & speeds

2.

Mark P Mathieu; Mark Mathieu
Published by PAREXEL International Corp (2000)
ISBN 10: 1882615557 ISBN 13: 9781882615551
Used Softcover Quantity Available: 1
Seller:
GlassFrogBooks
(Hawthorne, CA, U.S.A.)
Rating
[?]

Book Description PAREXEL International Corp, 2000. Condition: Good. A+ Customer service! Satisfaction Guaranteed! Book is in Used-Good condition. Pages and cover are clean and intact. Used items may not include supplementary materials such as CDs or access codes. May show signs of minor shelf wear and contain limited notes and highlighting. Seller Inventory # 1882615557-2-4

More information about this seller | Contact this seller

Buy Used
US$ 13.76
Convert currency

Add to Basket

Shipping: FREE
Within U.S.A.
Destination, rates & speeds

3.

Mark P Mathieu, Mark Mathieu
Published by PAREXEL International Corp
ISBN 10: 1882615557 ISBN 13: 9781882615551
Used Paperback Quantity Available: 1
Seller:
Free Shipping Books
(Toledo, OH, U.S.A.)
Rating
[?]

Book Description PAREXEL International Corp. Paperback. Condition: VERY GOOD. Light rubbing wear to cover, spine and page edges. Very minimal writing or notations in margins not affecting the text. Possible clean ex-library copy, with their stickers and or stamp(s). Seller Inventory # 2947796219

More information about this seller | Contact this seller

Buy Used
US$ 13.78
Convert currency

Add to Basket

Shipping: FREE
Within U.S.A.
Destination, rates & speeds

4.

Mathieu, Mark P; Mathieu, Mark
Published by PAREXEL International Corp
ISBN 10: 1882615557 ISBN 13: 9781882615551
Used Paperback Quantity Available: 1
Seller:
ThriftBooks
(Auburn, WA, U.S.A.)
Rating
[?]

Book Description PAREXEL International Corp. Paperback. Condition: Very Good. A copy that has been read, but remains in excellent condition. Pages are intact and are not marred by notes or highlighting, but may contain a neat previous owner name. The spine remains undamaged. At ThriftBooks, our motto is: Read More, Spend Less. Seller Inventory # G1882615557I4N00

More information about this seller | Contact this seller

Buy Used
US$ 38.08
Convert currency

Add to Basket

Shipping: FREE
Within U.S.A.
Destination, rates & speeds