Zobrazeno 1 - 10
of 21
pro vyhledávání: '"G K, Raju"'
Autor:
Andrea L, Koenigsberg, Veronica, Fowler, Reuben, Domike, Audrey, Brussel, Paul W, Barone, Flora J, Keumurian, James, Leung, Michael E, Wiebe, Michael T, Brewer, Shawn, Chan, Nicolas, Dumey, Anne, Fournillier, Marcella, Goodnight, Johanna, Kindermann, Richard, Leavy, Buyoung, Lee, Stefan, Minning, Marie, Murphy, Eric, Myers, Armen, Nahabedian, Kavita, Nanda, Sandi, Parriott, G K, Raju, Ciaran, Scallan, Stephanie, Schoch, Joe, Shiminsky, Bonnie, Shum, Sebastian, Teitz, Bernice, Westrek, Stacy, Springs
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 77:115-132
Some members of MIT's Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) previously published content on the ″Quality Risk Management in the Context of Viral Contamination″ which described tools, procedures, and methodolog
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b9140b063894d389a33167c931386f0
https://doi.org/10.5731/pdajpst.2021.012691
https://doi.org/10.5731/pdajpst.2021.012691
Publikováno v:
JCO Clin Cancer Inform
This work summarizes the benefit and risk of the results of clinical trials submitted to the US Food and Drug Administration of therapies for the treatment of non–small cell lung cancer (NSCLC) using number needed to benefit (NNB) and number needed
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::64bdc04d5dbced8894675f648c714e35
https://doi.org/10.1200/cci.19.00103
https://doi.org/10.1200/cci.19.00103
Autor:
Janet Woodcock, Karthik Gurumurthi, Chana Weinstock, Paul G. Kluetz, Richard Pazdur, Harpreet Singh, Reuben Domike, G. K. Raju
Publikováno v:
Clinical pharmacology and therapeutics. 107(3)
Drug regulators such as the US Food and Drug Administration (FDA) make decisions about drug approvals based on benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision making about new drugs to t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e2560118750769f7234a0f07b212f7e9
https://pubmed.ncbi.nlm.nih.gov/31355920
https://pubmed.ncbi.nlm.nih.gov/31355920
Autor:
Richard Pazdur, Karthik Gurumurthi, Reuben Domike, G. K. Raju, Marc R. Theoret, Janet Woodcock
Publikováno v:
Clinical pharmacology and therapeutics. 106(1)
Drug regulators seek to make decisions regarding drug approvals based on analysis of the relevant benefits and risks. In this work, 25 US Food and Drug Administration (FDA) decisions on melanoma drugs were identified and analyzed based on clinical tr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e3af009f0ddeb5d75c4195b32d2971aa
https://pubmed.ncbi.nlm.nih.gov/30993685
https://pubmed.ncbi.nlm.nih.gov/30993685
Autor:
Karthik Gurumurthi, Gideon M. Blumenthal, G. K. Raju, Dickran Kazandjian, Richard Pazdur, Reuben Domike, Janet Woodcock
Publikováno v:
Clinical Pharmacology & Therapeutics. 100:672-684
Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analyses. There is much interest in quantifying regulatory approaches to benefit and risk. In this work the use of a quantitative benefit-risk
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::586f282ceacececc3870585bc80b2223
https://doi.org/10.1002/cpt.501
https://doi.org/10.1002/cpt.501
Publikováno v:
Clinical Pharmacology & Therapeutics. 100:654-671
The analysis of benefit and risk is an important aspect of decision-making throughout the drug lifecycle. In this work, the use of a benefit-risk analysis approach to support decision-making was explored. The proposed approach builds on the qualitati
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31ef1754599080442b3714c38466057b
https://doi.org/10.1002/cpt.507
https://doi.org/10.1002/cpt.507
Autor:
Karthik Gurumurthi, Reuben Domike, Ann T. Farrell, Gideon M. Blumenthal, G. K. Raju, Dickran Kazandjian, Janet Woodcock, Richard Pazdur, Ola Landgren
Publikováno v:
Clin Pharmacol Ther
Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision-making about new drugs to treat multiple mye
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::45a56fc7e4e83b70807258171581f380
https://pubmed.ncbi.nlm.nih.gov/28901535
https://pubmed.ncbi.nlm.nih.gov/28901535
Autor:
Stephen W. Hoag, Janet Woodcock, Gregory E. Amidon, James E. Polli, Mansoor A. Khan, Lawrence X. Yu, G. K. Raju
Publikováno v:
The AAPS Journal. 16:771-783
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) o
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5e0cd39d8aadcc0d203d3b81e4d46eb8
https://doi.org/10.1208/s12248-014-9598-3
https://doi.org/10.1208/s12248-014-9598-3
Autor:
Mary Oates, Sau L. Lee, Tony Tong, Ganapathy Mohan, Giuseppe Randazzo, Michael P. Thien, Geoffrey K. Wu, Adam C. Fisher, Robert Ju, Richard T Lostritto, Emanuela Lacana, Bruce D. Johnson, Katherine M. Tyner, Stephen W. Hoag, Brian Hasselbalch, Grace McNally, Susan Rosencrance, Anna Schwendeman, Louis Yu, Moheb Nasr, Martin VanTrieste, Tara Gooen Bizjak, Henry A. Havel, Paul Seo, Siva Vaithiyalingam, Barbara Allen, Lawrence X. Yu, Ilgaz Akseli, Thomas F. O’Connor, Gregory E. Amidon, Ramesh Sood, Roger Nosal, Margaret Caulk, Ashley Boam, Janet Woodcock, Paula R Katz, Fionnuala Walsh, Robert Iser, Vinod P. Shah, Scott Furness, Larisa Wu, Russell Wesdyk, G. K. Raju, Joseph Famulare, Mahesh Ramanadham, Arzu Selen, Mehul Mehta, James E. Polli, David Doleski, Diane Zezza, Bernhardt L. Trout
Publikováno v:
The AAPS journal. 18(2)
The October 2015 FDA/PQRI Conference on Advancing Product Quality provided a forum for the exchange of ideas focused on drug product quality between regulatory agencies, the pharmaceutical industry, and academia. Key topics of the 2015 conference wer
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a4fa8e10c71dffd445e850573ee75ded
https://pubmed.ncbi.nlm.nih.gov/26860627
https://pubmed.ncbi.nlm.nih.gov/26860627
Autor:
Andre Raw, Filippos Kesisoglou, Lucinda F. Buhse, Russell Wesdyk, Sarah Pope Miksinski, E. J. Brandreth, Stephen P. F. Miller, Jeffrey Baker, Ashley Boam, Susan Rosencrance, Mohan Ganapathy, Sau L. Lee, Christine M. V. Moore, Gustavo Grampp, Robert Iser, Thomas Cosgrove, Gordon Johnston, Hayden Thomas, Paul Stinavage, David Doleski, Steven Kozlowski, Joerg Windisch, Emanuela Lacana, Lawrence X. Yu, Joseph Famulare, David Hussong, G. K. Raju, Mark Rosolowsky, S R Vaithiyalingam, Mansoor A. Khan, Susan C. Berlam, Lynne Ensor, Theresa Mullin
On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regul
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9aca655cbe6e3775e0f0ec8543d3f567
https://europepmc.org/articles/PMC4476989/
https://europepmc.org/articles/PMC4476989/
