CLINICAL PHARMACOLOGY POSTMARKETING STUDIES: A US FDA EVALUATION OF KNOWLEDGE GAPS AND TRANSLATION INTO LABELING.

被引:0
|
作者
Ridge, S. [1 ]
Guinn, D. [1 ]
Fletcher, E. Pfuma [1 ]
Zineh, I. [1 ]
Madabushi, R. [1 ]
Ramamoorthy, A. [1 ]
机构
[1] US FDA, Silver Spring, MD USA
关键词
D O I
暂无
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
PT-017
引用
收藏
页码:S66 / S67
页数:2
相关论文
共 44 条
  • [21] Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation
    Saito, Masami
    Iwasaki, Kiyotaka
    JOURNAL OF ARTIFICIAL ORGANS, 2017, 20 (01) : 62 - 70
  • [22] Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation
    Masami Saito
    Kiyotaka Iwasaki
    Journal of Artificial Organs, 2017, 20 : 62 - 70
  • [23] Regulatory considerations for non-clinical studies for COVID-19 vaccines: US FDA perspective
    Wrzesinski, C.
    TOXICOLOGY LETTERS, 2022, 368 : S30 - S31
  • [24] Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019-2023) by US FDA, best practices and recommendations
    Mitra, Amitava
    Lee, Jong Bong
    Steinbach, Douglas
    Hazra, Anasuya
    Krishna, Rajesh
    JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2023, 50 (06) : 475 - 493
  • [25] Building a framework for the evaluation of knowledge translation for the Canadian Network for Observational Drug Effect Studies
    Sketris, Ingrid S.
    Carter, Nancy
    Traynor, Robyn L.
    Watts, Dorian
    Kelly, Kim
    Ernst, Pierre
    Gamble, J. M.
    Hemmelgarn, Brenda
    Metge, Colleen
    Paterson, Michael
    Platt, Robert W.
    Teare, Gary
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2020, 29 : 8 - 25
  • [26] RECOMMENDATIONS OF THE GERMAN-SOCIETY-OF-CLINICAL-PHARMACOLOGY-AND-THERAPY-FOR-THE-CONDUCT-AND-EVALUATION-OF-PHARMACOLOGICAL-STUDIES
    BRECHT, JG
    JENKE, A
    KOHLER, ME
    HARDER, S
    THURMAN, P
    RIETBROCK, N
    MEDIZINISCHE KLINIK, 1995, 90 (09) : 541 - 546
  • [27] Spatially fractionated radiation therapy: a critical review on current status of clinical and preclinical studies and knowledge gaps
    Prezado, Yolanda
    Grams, Michael
    Jouglar, Emmanuel
    Martinez-Rovira, Immaculada
    Ortiz, Ramon
    Seco, Joao
    Chang, Sha
    PHYSICS IN MEDICINE AND BIOLOGY, 2024, 69 (10):
  • [28] FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective
    Bai, Jane P. F.
    Schmidt, Brian J.
    Gadkar, Kapil G.
    Damian, Valeriu
    Earp, Justin C.
    Friedrich, Christina
    van der Graaf, Piet H.
    Madabushi, Rajanikanth
    Musante, Cynthia J.
    Naik, Kunal
    Rogge, Mark
    Zhu, Hao
    AAPS JOURNAL, 2021, 23 (03):
  • [29] FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective
    Jane P. F. Bai
    Brian J. Schmidt
    Kapil G. Gadkar
    Valeriu Damian
    Justin C. Earp
    Christina Friedrich
    Piet H. van der Graaf
    Rajanikanth Madabushi
    Cynthia J. Musante
    Kunal Naik
    Mark Rogge
    Hao Zhu
    The AAPS Journal, 23
  • [30] In Vitro Evaluation of Magnetic Resonance Imaging Contrast Agents for Labeling Human Liver Cells: Implications for Clinical Translation
    Nathanael Raschzok
    David A. Muecke
    Michaela K. Adonopoulou
    Nils Billecke
    Wiebke Werner
    Nora N. Kammer
    Anja Zielinski
    Peter A. Behringer
    Frauke Ringel
    Mao D. Huang
    Peter Neuhaus
    Ulf Teichgräber
    Igor M. Sauer
    Molecular Imaging and Biology, 2011, 13 : 613 - 622