Drug Interaction Studies on New Drug Applications: Current Situations and Regulatory Views in Japan

2010 ◽  
Vol 25 (1) ◽  
pp. 3-15 ◽  
Author(s):  
Naomi Nagai
Keyword(s):  
Drug Interaction ◽  
New Drug ◽  
Interaction Studies

Drug interaction studies of esomeprazole with amoxicillin and clarithromycin

2001 ◽  
Vol 120 (5) ◽  
pp. A581-A581
Author(s):  
T ANDERSSON ◽  
L ASTRAZENECA ◽  
K ROHSS ◽  
M HASSANALIN
Keyword(s):  
Drug Interaction ◽  
Interaction Studies

Lurasidone drug-drug interaction studies: a comprehensive review

2014 ◽  
Vol 29 (3) ◽  
Author(s):  
Yu-Yuan Chiu ◽  
Larry Ereshefsky ◽  
Sheldon H. Preskorn ◽  
Nagaraju Poola ◽  
Antony Loebel
Keyword(s):  
Drug Interaction ◽  
Comprehensive Review ◽  
Interaction Studies ◽  
Drug Drug Interaction

scholarly journals A RAPID, SENSITIVE AND VALIDATED ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY AND TANDEM MASS SPECTROMETRY METHOD FOR DETERMINATION OF RIFAMPICIN IN RAT PLASMA: APPLICATION TO PHARMACOKINETIC STUDY

2017 ◽  
Vol 9 (2) ◽  
pp. 222
Author(s):  
Aslam Burhan ◽  
Bhavin Vyas
Keyword(s):  
Mass Spectrometry ◽  
Quality Control ◽  
Liquid Chromatography ◽  
Drug Interaction ◽  
Tandem Mass Spectrometry ◽  
Ultra Performance Liquid Chromatography ◽  
Rat Plasma ◽  
Tandem Mass ◽  
Plasma Samples ◽  
Interaction Studies

<p><strong>Objective: </strong>To develop and validate simple, sensitive and selective ultra-performance liquid chromatography and tandem mass spectrometry (UPLC-MS/MS) method for quantification of rifampicin (RIF) in rat plasma and its application to pharmacokinetics study.</p><p><strong>Methods: </strong>Precipitation method was used for the extraction of plasma samples, an aliquot of 25 µl plasma samples was extracted using acetonitrile precipitation technique. Chromatographic separation was performed usingWaters Acquity<sup>TM</sup>UPLC columns, BEH C18 (50 mm× 2.1 mm, 1.7 µm) by a gradient mixture of acetonitrile and water (both containing 0.1 % formic acid) as a mobile phase at the flow rate of 0.7 ml/min.The analyte was protonated in the positive ESI (electrospray ionization interface) and detected in MRM (multiple reactions monitoring) modes using the transition m/z 308.60-455.30.</p><p><strong>Results: </strong>The method had a short chromatography run time of 1.8 min with improved sensitivity over existing methods. Calibration curves been linear over the wide range of 1.97-5047.00 ng/ml. The between and within-batch precision and accuracy of the method was determined by using 4 quality control samples; the highest %CV observed was10.11. The mean recovery values are 74.26, 82.77 and 101.73 at low, medium and high-quality control levels; respectively.</p><p><strong>Conclusion: </strong>It was concluded that the developed and validated UPLC-MS/MS method was sensitive,specific, precise, linear, and rapid. Therefore, the method can be used for quantification of RIFin rat plasma with various advantages over the reported methods. RIF is widely recommended by US-FDAguidance for industry on drug interaction studies and the developed method can be used to explore drug interaction studies in drug discovery and development.</p>

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