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146 research outputs found

Elagolix Pharmacokinetic Profiles in Women With Renal or Hepatic Impairment

Author: U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER)
U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER)
Publication venue: 'Wiley'
Publication date
Field of study

Cardiovascular outcomes, heart failure and mortality in type 2 diabetic patients treated with glucagon‐like peptide 1 receptor agonists (GLP‐1 RAs): A systematic review and meta‐analysis of observational cohort studies

Author: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research
Publication venue: 'Wiley'
Publication date
Field of study

New drugs for Parkinson's disease: The regulatory and clinical development pathways in the United States

Author: Bhattaram
Garrett-Mayer
Kozauer
NINDS Exploratory Trials in Parkinson Disease (NET-PD) FS-ZONE Investigators
Olanow
Olanow
Sheiner
The NINDS NET-PD Investigators
Tilley
U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research
U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Science and Engineering Laboratories Office of Device Evaluation Division of Neurological and Physical Medicine Devices Neurostimulation Devices Branch
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)
Writing Group for the NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators
Publication venue: 'Wiley'
Publication date
Field of study

Science and Quality Assurance, part 2: PK/QA

Author: Goodman
Jones
OECD
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research
Wu
Publication venue: 'Wiley'
Publication date: 01/01/2005
Field of study

Pharmacologic activity and pharmacokinetics of metabolites of regorafenib in preclinical models

Author: U.S. Department of Health and Human Services U.S. Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Veterinary Medicine
Zopf D.
Publication venue: 'Wiley'
Publication date
Field of study

Analysis of the Potential for N

Author: Gnaiger E
Nevins TE
U.S. Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research
Publication venue: 'American Society for Microbiology'
Publication date
Field of study

One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults

Author: Craig P.
Fackrell K.
Hallam R. S.
Hsu C. C.
U.S. Department of Health and Human Services Food and Drug Administration
U.S. Department of Health Human Services Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, &amp
Publication venue: 'SAGE Publications'
Publication date
Field of study

Pharmacokinetics, Safety, and Clinical Outcomes of Omadacycline in Women with Cystitis: Results from a Phase 1b Study

Author: Huband MD
Sen A
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
Publication venue: 'American Society for Microbiology'
Publication date
Field of study

Investigation on the metabolic characteristics of isobavachin in Psoralea corylifolia

Author: U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER)
Venkatakrishnan K
Yang J
Publication venue: 'Wiley'
Publication date
Field of study

Mass spectrometry-based multiplexing for the analysis of biomarkers in drug development and clinical diagnostics — How much is too much?

Author: Annesley
Burckart
Christians
Clinical Laboratory and Standard Institute
Cummings
Dati
European Agency for the Evaluation of Medicinal Products
Goodsaid
Goodsaid
Goodsaid
Goodsaid
Haschke
Jacek Klepacki
Jelena Klawitter
Jost Klawitter
Klawitter
Klawitter
Lee
Lee
Müller
Nobeli
Oresic
Rifai
Touraj Shokati
U.S. Department of Health and Human Services Food and Drug Administration
U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research
U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research
U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research and Center for Veterinary Medicine
United States Food and Drug Administration Center for Drug Evaluation and Research
Uwe Christians
Wagner
Wickremsinhe
Publication venue: 'Elsevier BV'
Publication date
Field of study

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