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27 research outputs found
Simultaneous detection of lysine metabolites by a single LC–MS/MS method: monitoring lysine degradation in mouse plasma
Author
A Hallen
B Boulanger
+23Â more
BK Matuszewski
C Vallat
DS Wishart
EA Struys
F Papes
F Papes
Food Drug Administration Center for Drugs Evaluation Research
JC Baas
K Blemings
K Higashino
K Sadilkova
M Goncalves-Butruille
M Sugimoto
N Carson
P Arruda
P Markovitz
PB Mills
R Posset
RM Kok
SJ Vella
SS Iyer
SW Sauer
YE Chang
Publication venue
'Springer Science and Business Media LLC'
Publication date
Field of study
Get PDF
Crossref
Effects of renal impairment on the pharmacokinetics and pharmacodynamics of a novel dipeptidyl peptidase-4 inhibitor, evogliptin (DA-1229)
Author
Barnes
Davis
+17Â more
Deacon
Dicker
Dreisbach
Eynatten
Food and Drug Administration Center for Drugs Evaluation Research
Graefe-Mody
Gu
Herman
Hocher
Jung
Kim
Luo
Rhee
Shin
Shon
Tsuprykov
Websky
Publication venue
'Wiley'
Publication date
Field of study
No full text
Crossref
Gabapentin drug misuse signals: A pharmacovigilance assessment using the FDA adverse event reporting system
Author
Ahmed
Baird
+48Â more
Banda
Bate
Bisaga
Bockbrader
Center for Drug Evaluation and Research
Center for Drug Evaluation and Research
Chiappini
de Boer
Diener
Dowell
European Medicines Agency
European Monitoring Centre for Drugs and Drug Addiction
Evans
Fischer
Hamer
Hartnell
Hazell
Hochberg
Howard
Kapil
Moore
Pariente
Peterson
Poluzzi
Radley
Reeves
Reeves
Rodriguez
Roehrs
Satish
Scanlon
Schifano
Schwan
Smith
Smith
Smith
Szarfman
U.S. Department of Justice Drug Enforcement Administration Diversion Control Division
U.S. Food and Drug Administration
U.S. Food and Drug Administration
van Puijenbroek
Vickers Smith
Wang
Wilens
World Health Organization
World Health Organization
World Health Organization
Zhang
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
Advance in bioequivalence assessment of topical dermatological products
Author
Alvarez-Roman
Ao
+73Â more
Au
Au
Benfeldt
Boix-Montanes
Brunner
Brunner
Bunge
Caspers
Caspers
Chan
Chang
Chrit
Clough
Demana
Dempsey
Ding
Ding
Egawa
Fluhr
Flynn
Food and Drug Administration
Food and Drug Administration
Food and Drug Administration Center for Drug Evaluation and Research
Food and Drug Administration Department of Health and Human Services
Food and Drug Administration Department of Health and Human Services
Food and Drug Administration Department of Health and Human Services
Food and Drug Administration Office of Generic Drugs
Food and Drug Administration Office of Generic Drugs
Food and Drug Administration Office of Generic Drugs
Franz
Gao
Haigh
Herkenne
Herkenne
Holmgaard
Kalia
Kezic
Klimowicz
Kreilgaard
Lehman
Lionberger
Mak
Mateus
Mateus
Medendorp
Melot
Mohammed
N'Dri-Stempfer
Nallagundla
Narkar
Ortiz
Parfitt
Pershing
Pershing
Pershing
Poelman
Prausnitz
Puppels
Raney
Reddy
Schrolnberger
Shah
Shah
Shah
Shah
Singh
Sjogren
Tettey-Amlalo
Treffel
Trottet
Wiedersberg
Yacobi
Zhao
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
Safety, Tolerability, and Pharmacokinetic Characteristics of a Novel Nonopioid Analgesic, VVZ-149 Injections in Healthy Volunteers: A First-in-Class, First-in-Human Study
Author
Abbott
Aloyo
+25Â more
Bosilkovska
Caulfield
Dohi
Eulenburg
Food Drug Administration Center for Drugs Evaluation Research
Furlan
Harvey
Kato
Millan
Mingorance-Le Meur
Morita
National Research Council
Nersesyan
Nishikawa
Nishiyama
Okamoto
Pang
Pehek
Rosenblum
Rousseau
Steenwinckel
Wildt
Wilkinson
Xu
Zimmermann
Publication venue
'Wiley'
Publication date
Field of study
No full text
Crossref
ANTIRESORPTIVE AGENTS
Author
Division of Reproductive and Urologic Products Office of New Drugs, Division of Pharmacovigilance II, Office of Surveillance and Epidemiology, Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration
Malden
Marx
Schilcher
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
Dacarbazine (DTIC) versus vaccination with autologous peptide-pulsed dendritic cells (DC) in first-line treatment of patients with metastatic melanoma: a randomized phase III trial of the DC study group of the DeCOG
Author
Balch
Belardelli
+23Â more
Berger
Brossart
de Vries
Dhodapkar
Duffaud
Eigentler
Food and Drug Administration Center for Drug Evaluation and Research: Oncologic Drugs Advisory Committee. Briefing Material: May 3
Hauschild
Luongo
Middleton
Nestle
Pocock
Ridgway
Ridolfi
Rosenberg
Rosenberg
Scheibenbogen
Schuler-Thurner
Smith
Sosman
Therasse
Thurner
Thurner
Publication venue
'Oxford University Press (OUP)'
Publication date
Field of study
No full text
Crossref
Development of an algorithm to identify mass production candidate molecules to develop children’s oral medicines: a North American perspective
Author
A Dahan
C Milne
+27Â more
C Tannergren
C Vanchieri
Committee on Drugs
CY Wu
E Ramirez
EMA
G Charkoftaki
GL Amidon
Health Canada
HK Batchelor
HK Batchelor
J Piasecki
JT Flynn
LV Allen
M Almukainzi
MA Repka
MC Nahata
MM Crowley
MM Laughon
R Löbenberg
R Löbenberg
RH Parrish II
RK Jew
SM Abdel-Rahman
T Takagi
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
'Springer Science and Business Media LLC'
Publication date
Field of study
No full text
Crossref
Abuse-deterrent Opioid Formulations
Author
Institute for Clinical and Economic Review: Abuse-deterrent formulations of opioids: Effectiveness and value
Multistate Insider: States have stalled on potential opioid abuse solution: Deterrent formulation drugs
+15Â more
Office of National Drug Control Policy USA: National Drug Control Strategy
Office of National Drug Control Policy USA: National Heroin Task Force final report and recommendations
Pfizer Inc.: Embeda® (morphine sulfate and naltrexone HCl)
Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality: Results 2015 National Survey on Drug Use and Health: Detailed tables
U.S. Food and Drug Administration: Abuse-deterrent opioids—evaluation and labeling. Guidance for industry
U.S. Food and Drug Administration: Briefing document: Joint meeting of Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee
U.S. Food and Drug Administration: Center for Drug Evaluation and Research: Data and methods for evaluating the impact of opioid formulations with properties designed to deter abuse in the postmarket setting
U.S. Food and Drug Administration: Determination that the OxyContin (oxycodone hydrochloride) products covered by New Drug Application 20–553 were withdrawn from sale for reasons of safety or effectiveness
U.S. Food and Drug Administration: FDA actions on OxyContin products
U.S. Food and Drug Administration: FDA approves Targiniq ER with abuse-deterrent properties
U.S. Food and Drug Administration: FDA requests removal of Opana ER for risks related to abuse
U.S. Food and Drug Administration: Opioids action plan
U.S. Food and Drug Administration: Postmarketing safety issues related to reformulated Opana ER®
U.S. Food and Drug Administration: Sponsor briefing document: Arymo™ ER (morphine sulfate) extended-release tablets
U.S. Food and Drug Administration: Summary review for regulatory action: Hysingla® ER
Publication venue
'Ovid Technologies (Wolters Kluwer Health)'
Publication date
Field of study
No full text
Crossref
Considerations for mood and emotion measures in mindfulness-based intervention research
Author
American Psychiatric Association
Asmundson
+33Â more
Barrett
Cuijpers
Davidson
Delgadillo
Dinan
D’Agostino
Etkin
Farias
Fonzo
Food Drug Administration Center for Drugs Evaluation Research
Forbes
Gatti
Goldberg
Goyal
Gross
Harvey
Heimberg
Hoge
Leon
MacCoon
Mauss
Moller
Montgomery
Nairne
Onken
Ospina
Ospina
Rosenkranz
Shear
Shear
Smyth
Streiner
Wallis
Publication venue
'Elsevier BV'
Publication date
Field of study
No full text
Crossref
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