Volume 45, Number 6
NoVember 2011
ISSN 0092-8615
OFFICIAL PUBLICATION OF THE DRUG INFORMATION ASSOCIATION
CommeNTAr Y
Editor’s Commentary: A Time for Reflection and
Anticipation • J. Rick TuRneR • 687
Commentary: The Real-world Converging Pathways
of Comparative Effectiveness Research and Risk-Benefit Assessment • John J. Doyle • 691
Associate Editor’s Commentary: The Danger of
Shorting Drug Shortages • Pe TeR J. Pi TTs • 697
Fewer Drugs, Shorter Lives, Less Prosperity: The
Impact of Comparative Effectiveness Research on
Health and Wealth • John VeRnon • RobeRT GolDbeRG
• Pe TeR J. Pi TTs • JosePh h. Golec • 699
Preparing for a Safety Inspection • s TeVe Jolley •
705
leTTer To The edITor
Selection of the Time Points for a Thorough QTc
Study • Joanne ZhanG • noRman s TockbRiDGe • 713
ClINICAl TrIAlS
Ten-year Experience of the Evaluation of Ethnic
Sensitivity Data • chia-linG hsiao • younG-lianG lin
•li-FenG hsu • kuanG-yanG hsu • 717
Optimal Allocation of Prognostic Factors in
Randomized Preclinical Animal Studies • ZhenG su •
725
Platelet Aggregation Quality Control in a
Multicenter, Phase 2 Clinical Trial • James
mcReDmonD • 731
STATISTICS
A Longitudinal Model and Graphic for Benefit-risk
Analysis, With Case Study • Jona Than D. noRTon •
741
A Benefit-risk Model to Facilitate DMC-sponsor
Communication and Decision Making • anDReas
sasheGyi • 749
Validation of Decision-enabling Tools: Showing
That the Model Is Useful • niclas sJöGRen • s TiG
Johan WiklunD • 759
druG INFormATIoN
Evaluation of Drug Adverse Event Intake and
Reporting in a Medical Information Service •
Pamela D. allen • RobeRT J. Fuen Tes • michael J. hooPes
• GReG susla • 767
Failure to Communicate: Medication Guide or
Memory? • louis a. moRRis • moRRis s. Whi TcuP •
kei Th lama TTina • 775
Content Analysis of Off-label Drug Use: Reporting
Print Media Coverage • DiPen a. Pa Tel • aVani D. Joshi
• DaViD a. holDFoRD • kunal saxena • 787
Assessment of Electronic Drug Information
Resource Availability in Alabama Pharmacies • Pe TeR
J. huGhes • michael kenDRach • RobeRT h. schRimsheR
• TeRRi m. Wensel • maisha kelly FReeman • 797
Clinically Important Effects in New Drug
Development • kanae ToGo • nobushiGe ma Tsuoka •
sa Toshi hashiGaki • keiJi imai • Takashi moRiya •
805
Medical Information Services in the Age of Social
Media and New Customer Channels • Poonam
boRDoloi • anDRe W Gažo • kRuPa PaRanJPe • michelle
clausen • lesley FieRRo • 811
Certification for the Medical Science Liaison: An
Idea Whose Time Has Come—or Not • Jane chin •
kenne Th l. massey • Jimmy black • 819
booK reVIeW
Review of: Fundamentals of US Regulatory Affairs, 7th
ed. • eDWaRD TaboR •
825