Prescription Drug Advertising and Promotion: Learnings from Recent Food and Drug Administration Warning Letters Eric B. BensonSherman N. Alfors Drug Development 30 December 2007 Pages: 281 - 289
A Comparison of the Drug Review Process at Five International Regulatory Agencies Mayu HirakoNeil McAuslaneStuart Walker Drug Development 30 December 2007 Pages: 291 - 308
Exploratory IND Studies: A Review of Food and Drug Administration Guidance and Similar Provision in Europe Faraneh Attarchi Drug Development 30 December 2007 Pages: 309 - 314
Potential Predictors of Placebo Response: Lessons from a Large Database Richard EntsuahPhil Vinall Statistics 30 December 2007 Pages: 315 - 330
Revolutionizing the Role of Quality Assurance in Clinical Trials Patricia W. BrownMelissa P. Ball Quality Assurance 30 December 2007 Pages: 332 - 342
The Probability of Registrational Success Charles A. Maniglia Regulatory Affairs 30 December 2007 Pages: 345 - 347
The 505(b)(2) New Drug Application J. Christopher PrueArthur J. Mayorga Regulatory Affairs 30 December 2007 Pages: 349 - 352
Perspective on Quality Risk Management of Pharmaceutical Quality H. Gregg Claycamp Regulatory Affairs 30 December 2007 Pages: 353 - 367
Special Section on Clinical Research Standards Introduction Paul BleicherWayne KubickRebecca Kush Clinical Research Standard 30 December 2007 Pages: 369 - 371
Toward a Comprehensive CDISC Submission Data Standard Wayne R. KubickStephen RubergEdward Helton Clinical Research Standard 30 December 2007 Pages: 373 - 382
A Standard Computable Clinical Trial Protocol: The Role of the BRIDG Model Cara WilloughbyDoug FridsmaRebecca Kush Clinical Research Standard 30 December 2007 Pages: 383 - 392
Data Standards: At the Intersection of Sites, Clinical Research Networks, and Standards Development Initiatives Brian McCourtRobert A. HarringtonMeredith Nahm Clinical Research Standard 30 December 2007 Pages: 393 - 404
Controlled Terminology for Clinical Research: A Collaboration between CDISC and NCI Enterprise Vocabulary Services Margaret W. HaberBron W. KislerLawrence W. Wright Clinical Research Standard 30 December 2007 Pages: 405 - 412
7th Middle East Regulatory Conference (MERC) Elaine WhitingAfschin Khodaverdi-AfaghiMarie-Claire Beurier Proceedings 30 December 2007 Pages: 413 - 421