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Circadian Variation in QT Interval Demonstrating Assay Sensitivity in a Phase 1 Clinical Trial
Peter John Bourdillon
Drug Information Journal 2010 : 44(01)
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Reduction of Variability of Response-Adaptive Designs for Continuous Treatment Responses in Phase 3 Clinical Trials
Rahul Bhattacharya, Antanu Biswas
Drug Information Journal 2010 : 44(01)
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Rationale for Sponsor-unblinded Phase 1 Trials: Challenging the Doubleblind Paradigm
Jitendra Ganju, Clapton Dias
Drug Information Journal 2010 : 44(01)
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Leveraging Technology to Increase Efficiency and Quality for Regulatory SUbmissions
Terri M Booth-Genthe, Patricia Sichort
Drug Information Journal 2010 : 44(01)
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Standard Operating Procedures (SOPs): How Companies Can Determine Which Documents THey Must Put in Place
Michael R. Hamrell, Janet Gough
Drug Information Journal 2010 : 44(01)
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Biogeneric Regulatory Policies in China and India: A Comparison Study
Jeffery W. Guise, Benjamin M. Carson
Drug Information Journal 2010 : 44(01)
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Discussion Based on the Survey Results of Authorities Inquiries During NDA Review in Japan
Reiko Numazaki, Yutaka Kawakami, Chikara Kikuchi, Hirofumi Sone, Minako Kasuya, Kazumi Sunamura
Drug Information Journal 2010 : 44(01)
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Mentoring in the Pharmaceutical Industry: Developing an Effective Program for a Field-based Medical Team
Barb Schreiner, Jimmy Black
Drug Information Journal 2010 : 44(01)
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