Zobrazeno 1 - 10
of 47
pro vyhledávání: '"Justin L, Hay"'
Publikováno v:
Frontiers in Oncology, Vol 13 (2024)
Oncology drug discovery and development has always been an area facing many challenges. Phase 1 oncology studies are typically small, open-label, sequential studies enrolling a small sample of adult patients (i.e., 3-6 patients/cohort) in dose escala
Externí odkaz:
https://doaj.org/article/a33f9e0c7f654f328f3461dab95da55b
Autor:
Pieter Siebenga, Guido vanAmerongen, Justin L. Hay, Aoibhinn McDonnell, Donal Gorman, Richard Butt, Geert Jan Groeneveld
Publikováno v:
Clinical and Translational Science, Vol 13, Iss 2, Pp 318-324 (2020)
Sodium channel blockers are used for the treatment of pain, but this is limited by the lack of selectivity for different sodium channel subtypes, which can result in central nervous system and cardiovascular side effects. As such, there is special in
Externí odkaz:
https://doaj.org/article/00db826e397843549f2242867246cc5a
Autor:
Joshua Brown, Tamra Goodrow, Dan Hartman, Justin L. Hay, Kevin Hershberger, Susan Hershenson, Douglas McNair, Bethany Matthews, Mark A. Milad, Stephan Schmidt, Kirsten M Vogelsong, Ping Zhao
Publikováno v:
Contraception: X, Vol 4, Iss , Pp 100072- (2022)
Developing new long-acting products of well-characterized contraceptive drugs is one way to address some of the reasons for unmet need for modern methods of family planning among women in low- and middle-income countries. Development and approval of
Externí odkaz:
https://doaj.org/article/a9fca8cf75c04490838f743ef8553fe5
Autor:
Arzu Selen, Hao Zhu, Elimika Pfuma Fletcher, Shailly Mehrotra, Jack Cook, S.Y. Amy Cheung, Karen C. Thompson, Yuet Mei Khong, Lea Cunningham, Hari Cheryl Sachs, Jing Liu, Akhtar Siddiqui, Jian Wang, Vivek S. Purohit, Justin L. Hay
Publikováno v:
European Journal of Pharmaceutics and Biopharmaceutics. 164:66-74
A pediatric formulation workshop entitled "Pediatric Formulations: Challenges of Today and Strategies for Tomorrow" was held to advance pediatric drug product development efforts in both pre-competitive and competitive environments. The workshop had
Autor:
Marie-Christine Bielsky, Shahin Kauser, David Brown, Andrew Exley, Leonard Both, Andrea Wallington, Justin L. Hay, Anne Cook
Publikováno v:
Drug Discovery Today. 25:1910-1918
Licensing of biosimilars is essential to promote patient access to 21st-century biological medicines. Regulatory approval of biosimilars is based on the totality of evidence from a head-to-head comparison with reference products (RPs). A clinical eff
Autor:
Geert Jan Groeneveld, Guido van Amerongen, Pieter S. Siebenga, Richard P. Butt, Justin L. Hay, Aoibhinn McDonnell, Donal Gorman
Publikováno v:
Clinical and Translational Science, Vol 13, Iss 2, Pp 318-324 (2020)
Clinical and Translational Science
Clinical and Translational Science
Sodium channel blockers are used for the treatment of pain, but this is limited by the lack of selectivity for different sodium channel subtypes, which can result in central nervous system and cardiovascular side effects. As such, there is special in
Autor:
Pieter Okkerse, Guido van Amerongen, Rachel Gurrell, Pinky Dua, Richard P. Butt, Geert Jan Groeneveld, Pieter S. Siebenga, Mark Whitlock, Donal Gorman, Justin L. Hay
Publikováno v:
British Journal of Anaesthesia. 123:e194-e203
Background This study investigated the analgesic effects of two doses (15 and 65 mg) of PF-06372865, a novel α2/α3/α5 gamma-aminobutyric acid A (GABAA) subunit selective partial positive allosteric modulator (PAM), compared with placebo and pregab
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 118
The aim of this observational review was to review trends in deficiencies in clinical pharmacology dossiers by analysing the frequency and characteristics of major objections (MOs) related to clinical pharmacokinetics and dose-exposure-response (DER)
Autor:
Guido van Amerongen, Katrina Gore, Pinky Dua, Peter T. Loudon, Donal Gorman, Geert Jan Groeneveld, Richard P. Butt, Justin L. Hay, Pieter S. Siebenga
Publikováno v:
British Journal of Clinical Pharmacology. 84:301-309
Aim Inhibitors of nerve growth factor (NGF) reduce pain in several chronic pain indications. NGF signals through tyrosine kinase receptors of the tropomyosin-related kinase (Trk) family and the unrelated p75 receptor. PF-06273340 is a small molecule
Autor:
Nicholas H. G. Holford, Joseph F. Standing, Flora T. Musuamba, Norbert Benda, Andrew C. Hooker, Solange Corriol-Rohou, Frank Bretz, P H van der Graaf, Falk Ehmann, Martin Posch, I. Skottheim Rusten, S. Y. A. Cheung, Bjoern Bornkamp, Lena E. Friberg, Kristin E. Karlsson, James W.T. Yates, Robert Hemmings, A. Brochot, Efthymios Manolis, Neal Thomas, Susan Cole, Shampa Das, F. Serone, Valeria Gigante, Scott Berry, Thomas Dumortier, Justin L. Hay, Kayode Ogungbenro
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology. 6:418-429
Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by regul