10 research outputs found
Steering a course for risk assessment: The impact of new draft guidance, 21 CFR part 11, scope and application, on the electronic records; electronic signatures rule
- Author
- Publication venue
- 'Wiley'
- Publication date
- 01/01/2003
- Field of study
No full textAn Algorithmic Approach to Incorporating the Ich E2A Guidelines Into Safety Department ADR Reporting in the United States
- Author
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
No full textThe Changing Roles of Medical Communications Professionals: Evolution of the Core Curriculum
- Author
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
No full textU.S. Tax Shelter Regulations: A U.K. Reprise?
- Author
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2004
- Field of study
No full textWorst-Case Scenarios as a Stress Testing Tool for Risk Models
- Author
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2011
- Field of study
No full textAirport Infrastructure Investment
- Author
- Anselin L.
- Aviation Policy and Plans
- Churchill A. M.
- Cohen J. P.
- Elhorst J.
- Federal Aviation Administration Policy and Final Guidance Regarding Benefit Cost Analysis (BCA) on Airport Capacity Projects for FAA Decisions on Airport Improvement Program (AIP) Discretionary Grants and Letters of Intent (LOI)
- Jeffrey J. Eloff
- Jeffrey P. Cohen
- Kapoor M.
- Mitre Corporation
- Publication venue
- 'Transportation Research Board'
- Publication date
- Field of study
No full textDeveloping paediatric medicines: identifying the needs and recognizing the challenges
- Author
- AAP
- Alade
- Andou
- Arulanantham
- Aviv
- Balistreri
- Becton
- Bell
- Belson
- Brideau
- British National Formulary for Children (BNFC)
- British Paediatric Association/Association of British Pharmaceutical Industries
- Brown
- Brown
- Butchko
- Chau
- Coffey
- Conroy
- Conroy
- Cox
- Davies
- De Montis
- Dietemann-Molard
- DOH
- Drug and Alcohol Education and Prevention Team (DAEPT)
- Duke
- Dunne
- Edge
- Edwards
- Elder
- Elder
- EMEA
- EMEA
- EMEA
- Evans-Morris
- Fawzy
- FDA
- FDA
- Feldham
- Ford
- Geiling
- Gershanik
- Gershanik
- Goldkind
- Golightly
- Gottwald
- Guidance for Industry
- Guidance for Industry
- Guidance for Industry
- Guidance for Industry ICH E-11
- Guidott
- Guillet
- Kasturagi
- Kinoshita
- Kobayashi
- Kurasumi
- Kurtz
- Kyngas
- Lankford
- Lever
- Lovell
- LĂ©vesque
- MacDonald
- Maegaki
- MAFF
- Manek
- Martin
- Martin
- McCabe
- McCloskey
- Miura
- Monerat-Vautrin
- Motola
- Motola
- Mroz
- Mulhall
- Nair
- Nanda
- Nestaas
- Nishikawa
- Nitzan
- Noel
- Olthoff
- Owen
- Pairaudeau
- Pediatric Final Rule
- Pediatric Research Equity Act
- Pollock
- Prakesh
- Royal College of Paediatrics and Child Health (RCPCH) and the Neonatal and Paediatric Pharmacists Group
- Rusy
- Saleki-Gerhardt
- Seal
- Steinbrook
- Suarez
- Tan
- The UK Medicines for Children Research Network
- Tiner
- Toraishi
- Tuleu
- Ward
- Wehling
- Wehling
- WHO
- Wistow
- Wolraich
- Wong
- Woodcock
- Publication venue
- 'Royal Pharmaceutical Society'
- Publication date
- Field of study
No full textAssessing the Effectiveness of Strategies in US Birth Cohort Screening for Hepatitis C Infection
- Author
- Aamar
- AASLD-IDSA HCV guidance: Recommendations for testing managing, and treating hepatitis C
- Abu-Heija
- Abu-Heija
- Al-Hihi
- Allison
- Alter
- Belperio
- Bian
- Brillman
- Cartwright
- Center for Disease Control and Prevention
- Chou
- Cornett
- Defining the PCMH
- Dong
- Draft recommendation statement: Hepatitis C virus infection in adolescents and adults: Screening
- Eckman
- Federman
- Final recommendation statement: Hepatitis B virus infection: Screening 2014
- Flanigan
- Galbraith
- Gane
- Hall
- Hirode
- Hirode
- Hofmeister
- Hsieh
- Hyun
- Irvin
- Jones
- Justice
- Kahn
- Kelen
- Konerman
- Kruger
- Litwin
- Ly
- Lyons
- MacDonald
- Madhani
- Matin
- Mehta
- Minhas
- Moyer
- Nitsche
- NYS Hepatitis C Testing Law
- Patel
- Patel
- Rein
- Ross
- Saab
- Sarkar
- Satoskar
- Schechter-Perkins
- Sears
- Shen
- Shivkumar
- Smith
- Smith
- Smith
- Snelgrove
- Soo
- Soo
- Tang
- Teply
- Testing for
- Tomaszewski
- Travis
- Trowell
- Turner
- Turner
- Udompap
- Waheed
- White
- Wong
- Wong
- World Health Organization
- Yartel
- Yeboah-Korang
- Zou
- Publication venue
- 'Xia & He Publishing'
- Publication date
- Field of study
No full textAbuse-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
- 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
