A low p value indicates that the data are unlikely to have occurred in the presence of a true null, but the p value does not evaluate: 1) whether the null is actually true, that is, there actually is no drug effect, but the study sample was unusual or flawed; and 2) whether the ...
Economic evaluations during early (phase II) drug development : a role for clinical trial simu2 lations[J ] ? Pharmacoeconomics , 2001 ,19 :1069 - 1077.Economic evaluations during early (phase II) drug development: a role for clinical trial simulations? Pharmacoeconomics 2001 - DA, Walley...
Phase 2 and 3 combination designs to accelerate drug development. J Am Statist Assoc 2005; 100(470): 493-502Liu,Q,Pledger,GW.Phase 2 and 3 combination designs to accelerate drug development. Journal of the American Statistical Association . 2005...
Introduction: The development of new antimalarial drugs remains of the utmost importance, since Plasmodium falciparum has developed resistance against near... J Held,A Kreidenweiss,B Mordmüller - 《Expert Opinion on Drug Discovery》 被引量: 53发表: 2013年 Antimalarial Drug Development: Past to Pre...
I-SPY 2—a glimpse of the future of phase 2 drug development? N. Engl. J. Med. 375, 7–9 (2016). Article PubMed Google Scholar Das, S. & Lo, A. W. Re-inventing drug development: a case study of the I-SPY 2 breast cancer clinical trials program. Contemp. Clin. Trials 62,...
被引量: 2发表: 1989年 Recruitment of Volunteers for Phase I and Phase II Drug Development Studies Subject participation is crucial to drug development studies. Numbers of subjects are greatly reduced between the initial recruitment and study completion... BM Devries,GSH Jr,II Steven - 《Drug In...
aDuring the preclinical phase of drug development, Medical Affairs provides valuable perspective based on its understanding of alternative products and unmet medical needs. This insight can help produce a drug that addresses limitations in the current standard of care. 在preclinical阶段药物发展期间,医疗...
During this time period, there were 218 reported failures between phase II (including phase I/II) and submission (each drug indication combination is considered as a separate record and both new active substances and new indications of marketed drugs are included in the analysis). Of these ...
"There is an urgent need to upgrade the CSNS to meet the increasing demand of the users," said Zhang, adding that the phase II of the CSNS will support a wider range of research in fields such as magnetic superconducting quantum material, life science, drug development and catalytic material...
In a phase 2 trial of adults with neurofibromatosis type 1 and inoperable/growing plexiform neurofibromas, treatment with the MEK inhibitor selumetinib resulted in an objective response rate of 63.6% and improvement in other patient outcomes, with additional biopsy-based data providing further information...