Kogure, Seiji Koyama, Nobuyuki Hidaka, Shinji
Published in
Journal of clinical pharmacology
Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced subm...
Rutherford, Elaine Stewart, Graham Houston, J Graeme Jardine, Alan G Mark, Patrick B Struthers, Allan D
Published in
Journal of clinical pharmacology
Pal, Arindam Gautam, Anirudh Munjal, Sagar
Published in
Journal of clinical pharmacology
This 3-way, single-dose, randomized crossover study evaluated the pharmacokinetics (PK) and dose proportionality of 5-, 10-, and 15-mg doses of intranasal sumatriptan (DFN-02) coformulated with a permeation enhancer (DDM) in 18 healthy adults. The objective was to determine which DFN-02 dose approximates the PK of a 6-mg dose of sumatriptan deliver...
Marbury, Thomas C Berg, Jolene Kay Dove, Leonard S Covington, Paul S
Published in
Journal of clinical pharmacology
Bhattacharya, Indranil Manukyan, Zorayr Chan, Phylinda Heatherington, Anne Harnisch, Lutz
Published in
Journal of clinical pharmacology
Domagrozumab, a monoclonal antibody that binds to myostatin, is being developed for Duchenne muscular dystrophy (DMD) boys following a first-in-human study in healthy adults. Literature reporting pharmacokinetic parameters of monoclonal antibodies suggested that body-weight- and body-surface-area-adjusted clearance and volume of distribution estima...
Lau, S W Johnny Schlender, Jan-Frederik Abernethy, Darrell R Burckart, Gilbert J Golden, Adam Slattum, Patricia W Stegemann, Sven Eissing, Thomas
Published in
Journal of clinical pharmacology
Welling, Leonardo C Figueiredo, Eberval Gadelha
Published in
Journal of clinical pharmacology
Wagner, Christian Zhao, Ping Arya, Vikram Mullick, Charu Struble, Kimberly Au, Stanley
Published in
Journal of clinical pharmacology
Management of comorbidities and medications is complex in HIV-1-infected patients. The overall objective of this project was to develop separate physiologically based pharmacokinetic (PBPK) substrate models for the protease inhibitors darunavir and lopinavir. These protease inhibitors are used in the treatment of HIV infection. Both darunavir and l...
Greenberg, Rachel G Wu, Huali Laughon, Matthew Capparelli, Edmund Rowe, Stevie Zimmerman, Kanecia O Smith, P Brian Cohen-Wolkowiez, Michael
Published in
Journal of clinical pharmacology
Despite limited pharmacokinetic (PK) data, dexmedetomidine is increasingly being used off-label for sedation in infants. We aimed to characterize the developmental PK changes of dexmedetomidine during infancy. In this open-label, single-center PK study of dexmedetomidine in infants receiving dexmedetomidine per clinical care, ≤10 blood samples per ...
Aslanabadi, Naser Jafaripor, Iraj Sadeghi, Selda Hamishehkar, Hadi Ghaffari, Samad Toluey, Mehdi Azizi, Hanieh Entezari-Maleki, Taher
Published in
Journal of clinical pharmacology
Myocardial injury following elective percutaneous coronary intervention (PCI) occurs in about one-third of patients and is associated with mortality. Platelet aggregation, thrombosis formation, and inflammation are the main causes of cardiac injury during PCI. Vitamin D plays a key role in the cardiovascular system by exerting antiplatelet, anticoa...
