Multiple ascending dose

I Clinical pharmacology studies Single-ascending-dose safety, PK, and PD Multiple-ascending-dose safety, PK, and PD Proof of mechanism study... 

In human ADME studies, generally, a fixed dose selected from a single or multiple ascending dose study containing certain amount of radioactivity (50-100 xCi) is prepared in a formulation currently used in the clinic and dosed to each human subject. 

TQT smdies are typically conducted at some point following completion of single- and multiple-ascending dose (SAD and MAD) and maximum tolerable dose... 

Salvi V, Karnad D, Kothari S et al (2011) The contribution of early-phase clinictil data to a drug s integrated cardiac safety portfolio. J Clin Stud 3(1) 26-31 Shah RR, Morganroth J (2012) Early investigation of QTc liability the role of multiple ascending dose (MAD) study. Drug Saf 35 695-709... 

In a paper published electronically on June 24, 2016, Murphy and colleagues (Murphy et al. 2016) reported the use of concentration response (CR) modeling applied to data from two multiple ascending dose studies to examine the potential of lemborexant, a novel dual orexin receptor antagonist being developed to treat insomnia, to canse QT prolongation. The authors concluded as follows ... 

Shah RR, Morganroth J (2012) Early investigation of QTc liability the role of multiple ascending dose (MAD) study. Drug Saf 35 695—709... 

Santaris Pharma A/S (2010) Multiple ascending dose study of miravirsen in treatment-naive chronic hepatitis C subjects. Available at http //clinicaltrials.gov/ct2/show/NCT01200420. Last accessed 25 July 2011. US National Library of Medicine, Bethesda... 

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