-
1
-
-
0037648825
-
Guidelines and methodological reviews concerning drug abuse liability assessment
-
Balster RL, Bigelow GE (2003). Guidelines and methodological reviews concerning drug abuse liability assessment. Drug Alcohol Depend 70:S13-S40
-
(2003)
Drug Alcohol Depend
, vol.70
-
-
Balster, R.L.1
Bigelow, G.E.2
-
2
-
-
0021930767
-
Industry invites regulation: The passage of the Pure Food and Drug Act of 1906
-
Barkan ID (1985). Industry invites regulation: The passage of the Pure Food and Drug Act of 1906. Am J Public Health 75:18-26
-
(1985)
Am J Public Health
, vol.75
, pp. 18-26
-
-
Barkan, I.D.1
-
3
-
-
0004149550
-
-
Bureau Of Justice Statistics. Washington, DC US Department of Justice, Office of Justice Programs Available at
-
Bureau of Justice Statistics (1992). Drugs, crime and the justice system: A national report from the Bureau of Justice Statistics. Washington, DC: US Department of Justice, Office of Justice ProgramsAvailable at: Http:// www.bjs.gov/index.cfm?ty = pbdetail&iid = 4071. pp. 76-80
-
(1992)
Drugs, Crime And The Justice System: A National Report From The Bureau Of Justice Statistics
, pp. 76-80
-
-
-
5
-
-
34548593342
-
-
European Medicines Agency (EMA)Committee For Medical Products For Human Use (CHMP). EMA/CHMP/SWP/94227/2004. London, UK: European Medicines Agency 2006; Available at
-
European Medicines Agency (EMA)/Committee For Medical Products for Human Use (CHMP) (2006). Guideline of the non-clinical investigation on the dependence potential of medicinal products. EMA/CHMP/SWP/94227/2004. London, UK: European Medicines Agency 2006; Available at: Http:// www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/ 2009/09/WC500003360.pdf
-
(2006)
Guideline Of The Non-Clinical Investigation On The Dependence Potential Of Medicinal Products
-
-
-
6
-
-
84881558082
-
-
Food and Drug Administration (FDA Mitigation Strategy (REMS [Accessed 13 June 2013 Available at
-
Food and Drug Administration (FDA), Extended Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) (2012). Available at: Http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ UCM311290.pdf [Accessed 13 June 2013
-
(2012)
Extended Release (ER) Long-Acting (LA) Opioid Analgesics Risk Evaluation
-
-
-
7
-
-
0007212003
-
-
Federal Register. 244/ 19 December 2012/ Proposed Rules-[Docket No. DEA-369]. Schedules of controlled substances: Placement of lorcaserin into schedule IV
-
Federal Register (2012). Federal Register/Vol. 77, No. 244/19 December 2012/ Proposed Rules-[Docket No. DEA-369]. Schedules of controlled substances: Placement of lorcaserin into schedule IV.
-
(2012)
Federal Register
, vol.77
-
-
-
8
-
-
79952699074
-
-
Food and Drug Administration (FDA Center for Drug Evaluation and Research (CDERSilver Spring, MD: US Department of Health and Human Service 2010; Available at
-
Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER) (2010). Draft guidance for industry: Assessment of abuse potential of drugs. Silver Spring, MD: US Department of Health and Human Service 2010; Available at: Http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/UCM198650.pdf
-
(2010)
Draft Guidance For Industry: Assessment Of Abuse Potential Of Drugs
-
-
-
9
-
-
84865693205
-
-
Available at [Accessed 13 June 2013
-
Food and Drug Administration Safety and Innovation Act (FDASIA) (2012). Available at: Http://www.fda.gov/RegulatoryInformation/Legislation/Federal FoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ FDASIA/default.htm [Accessed 13 June 2013
-
(2012)
Food and Drug Administration Safety and Innovation Act (FDASIA
-
-
-
10
-
-
84886428695
-
-
Food and Drug Administration (FDA Center for Drug Evaluation and Research (CDER. Silver Spring, MD: FDA/CDER 2013; Available at
-
Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER) (2013). Draft guidance for industry: Abuse-Deterrent opioids-evaluation and labeling. Silver Spring, MD: FDA/CDER 2013; Available at: Http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryn formation/Guidances/UCM334743.pdf
-
(2013)
Draft guidance for industry: Abuse-Deterrent opioids-evaluation and labeling
-
-
-
11
-
-
2542465496
-
-
Available at [Accessed 13 June 2013]
-
Food and Drug Administration (FDA) Voice (2013). Available at: Http:// blogs.fda.gov/fdavoice/index.php/2013/04/the-science-of-Abuse- Deterrenceprogress-Toward-creating-safer-opioids/ [Accessed 13 June 2013
-
(2013)
Food and Drug Administration (FDA Voice
-
-
-
12
-
-
84881555787
-
-
Harrison Narcotics Tax Act. Available at [Accessed 13 June 2013
-
Harrison Narcotics Tax Act (1914). Public Acts of the Sixty-Third Congress of the United States. Available at: Http://www.naabt.org/documents/ Harrison- Narcotics-Tax-Act-1914.pdf; http://www.druglibrary.org/schaffer/ history/e1910/ harrisonact.htm [Accessed 13 June 2013
-
(1914)
Public Acts of the Sixty-Third Congress of the United States
-
-
-
13
-
-
80051794846
-
-
Health Canada. Ottawa, Ontario: Health Canada 2007; Available at
-
Health Canada (2007). Clinical assessment of abuse liability for drugs with central nervous system activity. Ottawa, Ontario: Health Canada 2007; Available at: Http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-Demande/ guide-Ld/abus/abuse-liability-abusif-usage-clin-eng.php
-
(2007)
Clinical Assessment Of Abuse Liability For Drugs With Central Nervous System Activity
-
-
-
17
-
-
84881558244
-
-
National Institute on Drug Abuse (NIDA) and Food and Drug Administration (FDA. Bethesda, Maryland: NIDA and FDA 2011; Available at
-
National Institute on Drug Abuse (NIDA) and Food and Drug Administration (FDA) (2011). Science of abuse liability assessment. Bethesda, Maryland: NIDA and FDA 2011; Available at: Http://www.seiservices.com/nida/ 1014102/agenda.aspx
-
(2011)
Science Of Abuse Liability Assessment
-
-
-
18
-
-
33847112769
-
Overview of drug control: A regulatory primer on scheduling and controlled substance regulations
-
Parker JM (2006). Overview of drug control: A regulatory primer on scheduling and controlled substance regulations. Clin Res Regul Aff 23:211-225
-
(2006)
Clin Res Regul Aff
, vol.23
, pp. 211-225
-
-
Parker, J.M.1
-
19
-
-
84881556876
-
-
PhRMA-FDA Dialogue Session. Available at [Accessed 13 June 2013
-
PhRMA-FDA Dialogue Session (2008). Abuse potential assessment. Available at: Http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedical ProductsandTobacco/CDER/UCM180769.pdf [Accessed 13 June 2013
-
(2008)
Abuse Potential Assessment
-
-
-
20
-
-
84881553344
-
-
Pure Food Drug Act. United States Statutes at Large (59th Cong., Sess. I, Chapter 3915, pp; cited as 34 US Stats. 768
-
Pure Food and Drug Act (1906). Alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, Cannabis indica, chloral hydrate, acetanilide or any derivative or preparation thereof. United States Statutes at Large (59th Cong., Sess. I, Chapter 3915, pp. 768-772; cited as 34 US Stats. 768
-
(1906)
Alcohol, Morphine, Opium, Cocaine, Heroin, Alpha Or Beta Eucaine, Chloroform, Cannabis Indica, Chloral Hydrate, Acetanilide Or Any Derivative Or Preparation Thereof
, pp. 768-772
-
-
-
21
-
-
84884875385
-
Chapter 7: Development of medications for heroin and cocaine addiction and regulatory aspects of abuse liability testing
-
In: MacArthur RA, Borsini F, editors Burlington, MA Academic Press, an imprint of Elsevierpp
-
Rocha BA, Bergman J, Comer SD, Haney M, Spealman RD (2008). Chapter 7: Development of medications for heroin and cocaine addiction and regulatory aspects of abuse liability testing. In: MacArthur RA, Borsini F, editors. Animal and translational models for CNS drug discovery. Vol. 3: Burlington, MA: Academic Press, an imprint of Elsevierpp. 223-270
-
(2008)
Animal And Translational Models For Cns Drug Discovery
, vol.3
, pp. 223-270
-
-
Rocha, B.A.1
Bergman, J.2
Comer, S.D.3
Haney, M.4
Spealman, R.D.5
-
22
-
-
84887319059
-
Companies unite to advance regulatory landscape of abuse potential assessment
-
Rocha BA, Martynowicz H, Usher RW, Friedman A, Parker J, Fanelli R, et al. (2011). Companies unite to advance regulatory landscape of abuse potential assessment. Regul Focus 16:8-13
-
(2011)
Regul Focus
, vol.16
, pp. 8-13
-
-
Rocha, B.A.1
Martynowicz, H.2
Usher, R.W.3
Friedman, A.4
Parker, J.5
Fanelli, R.6
-
23
-
-
84881553077
-
-
Title 21 United States Code (USC) Controlled Substances Act Section 801 (21USC801 Available at [Accessed 13 June 2013
-
Title 21 United States Code (USC) Controlled Substances Act, Section 801 (21USC801), congressional findings and declarations: Controlled substances. Available at: Http://www.deadiversion.usdoj.gov/21cfr/21usc/ 801.htm [Accessed 13 June 2013
-
Congressional Findings And Declarations: Controlled Substances
-
-
-
24
-
-
84881553783
-
-
Title 21 United States Code (USC Available at [Accessed 13 June 2013
-
Title 21 United States Code (USC) Controlled Substances Act, Section 802 (21USC802)-Definitions. Available at: Http://www.deadiversion.usdoj.gov/ 21cfr/21usc/802.htm [Accessed 13 June 2013
-
Controlled Substances Act Section 802 (21USC802)-Definitions
-
-
-
26
-
-
84881547722
-
-
World Health Organization Available at
-
World Health Organization United Nations Single Convention on Narcotic Drugs (1961). Available at: Http://www.unodc.org/unodc/en/treaties/single- convention. html?ref =menuside
-
(1961)
United Nations Single Convention on Narcotic Drugs
-
-
-
27
-
-
84881557347
-
-
World Health Organization Available at
-
World Health Organization United Nations Convention on Psychotropic Substances (1971). Available at: Http://www.unodc.org/pdf/convention- 1971-en.pdf
-
(1971)
United Nations Convention on Psychotropic Substances
-
-
|