15 research outputs found
Evaluation of the effect of dapagliflozin on cardiac repolarization: a thorough QT/QTc study
- Author
- Publication venue
- Springer Healthcare Communications
- Publication date
- 01/01/2011
- Field of study
Get PDFAnalysis of US Food and Drug Administration Warning Letters
- Author
- A Caplovitz
- AG Benbow
- AN Thomson
- B Tansey
- DA Kessler
- EA Almasi
- ER Berndt
- HA Waxman
- J Dana
- L Abenhaim
- M Baylor-Henry
- M Croasdale
- MA Steinman
- MG Ziegler
- MT Gahart
- P Norman
- R Tiner
- R Vaithianathan
- RM Halperin
- TA Brennan
- US Department of HealthHuman Services FoodDrug Administration.
- US Department of Justice.
- US FoodDrug Administration.
- US FoodDrug Administration.
- US FoodDrug Administration.
- US FoodDrug Administration. US FoodDrug Administration.
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
No full textSources of Drug Information Available to Consumers
- Author
- AF Holmer
- B Chi-Lum
- BB Virshup
- C o E Statistics National
- CL Hatfield
- F Hopkins
- J Choi
- KN Reeves
- LR Bradley
- M Perri
- MA Moberg
- MF Hollon
- R Moynihan
- RA Bell
- RA Bell
- Title 21 Code of Federal Regulations.
- US Department of HealthHuman Services FoodDrug Administration.
- US Department of HealthHuman Services FoodDrug Administration.
- W Levinson
- W Levinson
- WL Pines
- WR Doucette
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
No full textRelationship Between Progression-Free Survival and Overall Survival Benefit: A Simulation Study
- Author
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
No full textFrom “Too Much, Too Late” to “Right First Time”: Quality Guru Deming’s Advice for Clinical Trials
- Author
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
No full textSurvey of Safety Information in the Investigator’s Brochure: Inconsistencies and Recommendations
- Author
- Council for International Organizations of Medical Sciences
- Council for International Organizations of Medical Sciences
- Council for International Organizations of Medical Sciences
- European Commission. Communication from the Commission
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- P Archdeacon
- The European Parliamentthe Council of the European Union
- US Department of HealthHuman Services FoodDrug Administration, Center for Drug EvaluationResearch
- US Department of HealthHuman Services FoodDrug Administration, Center for Drug EvaluationResearch, Center for Biologics EvaluationResearch
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
No full textPatient-Centered Therapy Development for Myotonic Dystrophy: Report of the Myotonic Dystrophy Foundation–Sponsored Workshop
- Author
- C Campbell
- C Gagnon
- C Gagnon
- C Heatwole
- C Heatwole
- C Heatwole
- CJ Mann
- CM McDonald
- HC Roberts
- K Norman
- L Laberge
- M Nakamori
- M Ryan
- NE Johnson
- Quantum of effectiveness evidence in FDA’s approval of orphan drugs: update July 2010 to June 2014
- S Amur
- US Department of HealthHuman Services FoodDrug Administration, Center for Drug EvaluationResearch CDER, Center for Biologics EvaluationResearch CBER, Center for DevicesRadiological Health CDRH
- US FoodDrug Administration
- US FoodDrug Administration
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
No full textReducing the Abuse Potential of Controlled Substances
- Author
- AM Gilson
- AM Wisniewski
- B Jung
- B Meier
- C Baum
- C Schmidt
- Centers for Disease ControlPrevention
- CG McCormick
- CJ Acker
- College on Problems of DrugDependence
- CR Schuster
- Crosse M. U.S
- CW Gorodetzky
- D Brookoff
- DA Parasrampuria
- DE Joranson
- DM Goldenbaum
- Drug Enforcement Administration
- Durect Corporation
- Durect Corporation
- Durect Corporation
- E Seoane-Vazquez
- EL May
- FoodDrug Administration
- FoodDrug Administration
- FoodDrug Administration
- FoodDrug Administration
- FoodDrug Administration
- FoodDrug Administration Center for Drug EvaluationResearch
- FoodDrug Administration Center for Drug EvaluationResearch
- FoodDrug Administration Center for Drug EvaluationResearch
- FoodDrug Administration Office of Clinical Pharmacology, Center for Drug EvaluationResearch
- HighBeam Research
- J Zacny
- JA Inciardi
- Janssen Pharmaceutica LP
- JJ Coleman
- JS Li
- Justia US Laws
- JY Wick
- K Hohenstein
- King Pharmaceuticals Inc
- L Webster
- LA Fingerhut
- LP Purdue Pharma
- LR Webster
- M Perrone
- N Dasgupta
- N Katz
- NB Eddy
- ND Reaves
- ND Volkow
- ND Volkow
- NDCHealth
- Office of National Drug Control Policy
- P Greene
- PJ Fudala
- R Mathias
- Reckitt Benckiser Pharmaceuticals
- S McColl
- S Novak
- SD Passik
- SE McCabe
- Shire Pharmaceuticals
- SR Calhoun
- States by urban-rural statusby drug type
- Substance AbuseMental Health Services Administration
- Substance AbuseMental Health Services Administration Office of Applied Studies
- Substance AbuseMental Health Services Administration Office of Applied Studies
- Substance AbuseMental Health Services Administration Office of Applied Studies
- Substance AbuseMental Health Services Administration Office of Applied Studies Drug Abuse Warning Network
- TJ Cicero
- TJ Spencer
- TJ Spencer
- U.S. Department of Justice Drug Enforcement Administration
- U.S. Department of Justice Drug Enforcement Administration
- U.S. Senate Committee on Health Education, Labor,Pensions
- United Nations
- US Department of HealthHuman Services US FoodDrug Administration
- Wolters Kluwer Health Inc
- YW Wick
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
No full textDrug Approval Times and User Fees
- Author
- Australian National Audit Office.
- Australian National Audit Office.
- B Mintzes
- C Anderson
- CBC-TV Disclosure.
- Center for Drug EvaluationResearch US Department of HealthHuman Services.
- D Carpenter
- D Carpenter
- Drugs Directorate.
- ER Berndt
- Fooddrug administration amendments act of 2007
- FR Lichtenberg
- FR Lichtenberg
- FR Lichtenberg
- FR Lichtenberg
- FR Lichtenberg
- G Stigler
- GE Miller
- GW Lawson
- H Lofgren
- Health Canada.
- Health Canada.
- Health Canada.
- Health Canada.
- IMS Health.
- J Abraham
- J Abraham
- J Abraham
- J Lexchin
- J Lexchin
- JL Zelenay Jr
- K Griffiths
- KE Lasser
- KPMG Consulting LP.
- M Angell
- M Goozner
- M Mamdani
- M McClellan
- MA Friedman
- MI Hunt
- MK Olson
- MK Olson
- N Duckwitz
- NSB Rawson
- NSB Rawson
- Office of Inspector General.
- P Baume
- P Lurie
- Patented Medicine Prices Review Board.
- PJ Hilts
- R Joppi
- RG Peterson
- Rx&D.
- Rx&D.
- S Christensen
- S Garattini
- S Hennessy
- S Okie
- Therapeutic Products Directorate.
- US FoodDrug Administration Office of Planning.
- US FoodDrug Administration.
- US FoodDrug Administration.
- US FoodDrug Administration.
- US FoodDrug Administration.
- US FoodDrug Administration.
- US FoodDrug Administration.
- US General Accounting Office.
- Y Zhang
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
No full textOptimizing Drug Development Programs: Type 2 Diabetes Case Study
- Author
- A Ivanova
- A O’Hagan
- B Bornkamp
- B Gaydos
- C-F Burman
- D Bernoulli
- DA Berry
- DJ Spiegelhalter
- DJ Spiegelhalter
- J Pinheiro
- M West
- N Benda
- Nitin R. Patel
- NR Patel
- NR Patel
- P Bauer
- US Department of HealthHuman Services FoodDrug Administration, Center for Drug EvaluationResearch CDER.
- V Dragalin
- Z Antonijevic
- Z Antonijevic
- Z Antonijevic
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
No full text
