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15 research outputs found

Statistical considerations on implementing the MCP-Mod method for binary endpoints in clinical trials

Author: Bretz
European Medicines Agency (EMA)
Kaitin
Pinheiro
Pinheiro
Sacks
USA Food and Drug Administration (FDA)
Wang
Zhou
Publication venue: 'Elsevier BV'
Publication date
Field of study

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
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Determination that the OxyContin (oxycodone hydrochloride) products covered by New Drug Application 20–553 were withdrawn from sale for reasons of safety or effectiveness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

Crossref

Drug excipients, food additives, and cosmetic ingredients probably not carcinogenic to humans reveal a functional specificity for the 2‐year rodent bioassay

Author: Eaton D. L.
EFSA (European Food Safety Authority)
EFSA (European Food Safety Authority)
EFSA (European Food Safety Authority)
EFSA (European Food Safety Authority)
EFSA (European Food Safety Authority)
EFSA (European Food Safety Authority)
Gordis L.
IARC (International Agency for Research on Cancer)
IARC (International Agency for Research on Cancer)
IARC (International Agency for Research on Cancer)
IARC (International Agency for Research on Cancer)
IARC (International Agency for Research on Cancer)
IARC (International Agency for Research on Cancer)
IARC (International Agency for Research on Cancer)
IARC (International Agency for Research on Cancer)
ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
JMPR (Joint FAO/WHO Meeting on Pesticide Residues)
Laan J. W.
McConnell EE
Mendrala A. L.
Miller D. C.
Morris H. J.
OECD (Organisation for Economic Co‐operation and Development)
OECD (Organisation for Economic Co‐operation and Development)
UK COM (Committee on Mutagenicity of Chemicals in Food Consumer Products and the Environment)
USA EPA (Environmental Protection Agency)
USA EPA (Environmental Protection Agency)
USA EPA (Environmental Protection Agency)
USA FDA (Food and Drug Administration)
USA FDA (Food and Drug Administration)
USA FDA (Food and Drug Administration)
USA FDA (Food and Drug Administration)
USA FDA (Food and Drug Administration)
USA FDA (Food and Drug Administration)
USA NIOSH (National Institute for Occupational Safety and Health)
Verschuuren H. G.
WHO (World Health Organization)
Publication venue: 'Wiley'
Publication date
Field of study

Crossref

Impact of Product Attributes on Preclinical Safety Evaluation

Author: Baillie
Brown
Buckley
Bugelski
Bussiere
Cavagnaro
Chapman
Cizeau
Clarke
Clarke
DeGeorge
Descostes
EMA
EMA
EMA
Faqi
FDA
Frokjaer
Hamuro
Herzyk
Herzyk
Huang
ICH M3
ICH M3 (R1)
ICH M3 (R2)
ICH S1A
ICH S1B
ICH S2(R1)
ICH S3A
ICH S5 (R2)
ICH S6
ICH S6 (R1)
ICH S7A
ICH S8
ICH S9
Jacobson-Kram
Kelly
Koppele
Leach
Lee
Martin
Mohanraj
Morford
Murayama
Ponce
Qu
Scharton-Kersten
Schober
Sharma
Storer
Subramanyam
Tibbitts
Tolcher
Tsai
USA Food and Drug Administration
USA Food and Drug Administration
USA Food and Drug Administration
Vahle
Vargasa
Wu
Publication venue: 'Elsevier BV'
Publication date: 01/01/2013
Field of study

Crossref

Comparative Efficacy of Anesthetics for the Freshwater Prawn Macrobrachiurn rosenbergii

Author: Administration: Center for Veterinary Medicine Dockets Management Branch, Rockville, Maryland, USA. Gardner, C.
Alias
Anderson
Brown
Coyle
Coyle
D'Abramo
Econometric Software Inc.
Food and Drug Administration (FDA).
Greene
Harvey
Jensen
Morgan
Munday
Nagababu
Ozeki
Schnick
Smith
Soto
Summerfelt
Taylor
Tidwell
Tidwell
Tidwell
Tidwell
Tidwell
Tidwell
Zar
Publication venue: 'Wiley'
Publication date
Field of study

Crossref

Surface and mechanical analysis of explanted Poly Implant Prosthèse silicone breast implants

Author: Adams
Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)
Australian Government Department of Health and Ageing Therapeutic Goods Administration (TGA)
Berry
Bosch
Bosch
Donlan
Hammond
Kaali
Keogh
Necchi
O'Neill
Scala
Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)
Tan
UK National Health Service (NHS)
UK National Health Service (NHS) Choices
USA Food and Drug Administration (FDA)
Publication venue: 'Wiley'
Publication date
Field of study

Crossref

Ohmic-assisted hydrodistillation of essential oils from Zataria multiflora Boiss (Shirazi thyme)

Author: AACC
Afhsari-Jouibari
Ali
Baranauskiene
Cabo
FCC
Ferhat
Golmakani
Golmakani
Goullieux
Hosseinzadeh
Hudaib
Imai
Jalas
Jalas
Jalas
Javidnia
Javidnia
Knirsch
Kováts
Moyler
Presti
Saharkhiz
Sastry
Sastry
Sastry
Senatore
Simon
Stahl-Biskup
Stahl-Biskup
Stashenko
Stashenko
Tigrine-Kordjani
USA-FDA. United States of America Food and Drug Administration, Center for Food Safety and Applied Nutrition
Vandendool
Vicente
Yam
Publication venue: 'Wiley'
Publication date
Field of study

Crossref

The purpose of this article is providing readers basic and newest principles about chemical structures of b-glucan and psyllium and theirconnections with molecular features, rheological behavior, and physiological consequences. Thus, differences and similarities between themappear. This work also shows the impact that functional properties could have for the food industry in the challenge of producing functionalfoods acceptable to the consumers.Fil: Figueroa, Lilian Elisa. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; ArgentinaFil: Dello Staffolo, Marina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina. Universidad Nacional de La Plata. Facultad de Ingeniería. Departamento de Ingeniería Química; Argentin

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