Zobrazeno 1 - 10
of 15
pro vyhledávání: '"Lorrene A. Buckley"'
Autor:
Ilona Bebenek, Caitlin Murphy, Lorrene A. Buckley, Hanan N. Ghantous, Eric C. Jensen, Aimee Hodowanec, Paul D. Cornwell
Publikováno v:
International Journal of Toxicology. 39:379-396
Drug development is a term used to define the entire process of bringing a new drug or device to market. It is an integrated, multidisciplinary endeavor that includes drug discovery, chemistry and pharmacology, nonclinical safety testing, manufacturi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4a092df1d3e383ddb739e482ddabf546
https://doi.org/10.1177/1091581820939083
https://doi.org/10.1177/1091581820939083
A cross-industry survey on photosafety evaluation of pharmaceuticals after implementation of ICH S10
Autor:
Laure Delafoy, Helga Gerets, Betty Pettersen, Douglas C. Bauer, Jonathan Howe, Heidrun Ellinger-Ziegelbauer, John Nicolette, Lorrene A. Buckley, Brian Schimpf, Gerry Kaijser, Mick D. Fellows
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 125
A cross-industry survey was conducted by EFPIA/IQ DruSafe in 2018 to provide information on photosafety evaluation of pharmaceuticals after implementation of ICH S10. This survey focused on the strategy utilized for photosafety risk assessment, the d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d5f027468b0b535ab9526b88c4eb56f4
https://pubmed.ncbi.nlm.nih.gov/34311056
https://pubmed.ncbi.nlm.nih.gov/34311056
Autor:
Smita Salunke, Karen C Thompson, Darren Fegley, Gerri Baer, Lorrene A. Buckley, Mark A. Turner
Publikováno v:
INTERNATIONAL JOURNAL OF PHARMACEUTICS
A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric ag
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::20b21dc659c99d9e0d03f28004c89abf
https://pubmed.ncbi.nlm.nih.gov/28729174
https://pubmed.ncbi.nlm.nih.gov/28729174
Autor:
Philip W. Iversen, Joseph A. Jakubowski, James J. Starling, Lorrene A. Buckley, Mary Pat Knadler, Atsushi Sanbuissho
Publikováno v:
International Journal of Toxicology. 31:317-325
Prasugrel, a thienopyridine ADP receptor antagonist, is an orally administered prodrug requiring in vivo metabolism to form the active metabolite that irreversibly inhibits platelet activation and aggregation mediated by the P2Y12[sub 12] receptor. A
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::87ae432d900c01ac7e6508604a7570a1
https://doi.org/10.1177/1091581812445073
https://doi.org/10.1177/1091581812445073
Autor:
Jessica Couch, Anne Seitske de Boer, Nicholas Pullen, Kathryn Chapman, Laura Andrews, Lorrene A. Buckley, Paul Baldrick, Lauren E. Black, C. Ian Ragan, A. Maggie Dempster, Lee A Coney, Jennifer Sims, Keith Jones, Lolke de Haan, Jeffrey J. Bajramovic, Christopher J. Bowman
Publikováno v:
Regulatory Toxicology and Pharmacology. 62:347-354
The changing environment of monoclonal antibody (mAb) development is impacting on the cost of drug development and the use of experimental animals, particularly non-human primates (NHPs). The drive to reduce these costs is huge and involves rethinkin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fb03c3e91b85ccf74e5ae451c19de690
https://doi.org/10.1016/j.yrtph.2011.10.016
https://doi.org/10.1016/j.yrtph.2011.10.016
Autor:
Kathryn Chapman, Janice A. Lansita, Pauline L. Martin, Marque Todd, Leigh Ann Burns-Naas, Lorrene A. Buckley
Publikováno v:
International Journal of Toxicology. 30:583-590
Selection of a pharmacologically responsive species can represent a major challenge in designing nonclinical safety assessment programs for many biopharmaceuticals (eg, monoclonal antibodies (mAbs)). Frequently, the only relevant species for nonclini
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9cfbae8b9da0364415f8a04dcb0b661f
https://doi.org/10.1177/1091581811415875
https://doi.org/10.1177/1091581811415875
Publikováno v:
Genotoxicity and Carcinogenicity Testing of Pharmaceuticals ISBN: 9783319220833
Potential signals of human carcinogenicity may arise in the course of clinical development or post marketing experience for a drug having shown a lack of evidence of a carcinogenic risk in nonclinical studies. It is always possible that, given the sm
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::733f99ddf45396fae2795a0326b477be
https://doi.org/10.1007/978-3-319-22084-0_10
https://doi.org/10.1007/978-3-319-22084-0_10
Autor:
Lorrene A. Buckley
Publikováno v:
Toxicology. 102:125-131
Significant advances have been made in the development of physiologically-based models of dioxin pharmacokinetics (PBPK) in the last 5-6 years. These models incorporate explicit descriptions of biological factors which determine tissue dosimetry of d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a95a1d31caf58d6f5f9f5629e409faec
https://doi.org/10.1016/0300-483x(95)03041-d
https://doi.org/10.1016/0300-483x(95)03041-d
Autor:
Betty J. Eidemiller, Gary P. Carlson, Teresa L. Leavens, Vanessa A. Fitsanakis, Dori R. Germolec, Courtney E. W. Sulentic, Lois D. Lehman-McKeeman, Mary Beth Genter, Aaron Barchowsky, Lorrene A. Buckley, Sue M. Ford, Stephen Safe
Toxicology and careers in toxicology, as well as many other scientific disciplines, are undergoing rapid and dramatic changes as new discoveries, technologies, and hazards advance at a blinding rate. There are new and ever increasing demands on toxic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dc50a39a3c326f4d42187e7e5fcebeb9
https://europepmc.org/articles/PMC3355314/
https://europepmc.org/articles/PMC3355314/
Autor:
Michael A. Dorato, Lorrene A. Buckley
Publikováno v:
Current Protocols in Pharmacology
The primary objective of toxicology studies in the drug development process is to evaluate the safety of potential drug candidates using relevant animal models and validated procedures. The ultimate goal is to interpret the animal data to assess risk
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d4bfc2cb51012b59c60e23816ffea224
https://pubmed.ncbi.nlm.nih.gov/22294168
https://pubmed.ncbi.nlm.nih.gov/22294168