Day NL, Leech SL, Goldschmidt L The effects of prenatal marijuana exposure on delinquent behaviors are mediated by measures of neurocognitive functioning. Neurotoxicol Teratol. 2011 Jan-Feb;33(1):129-36. doi: 10.1016/j.ntt.2010.07.006.
Feldman RM Smokeless tobacco spoils more than the world series. Todays FDA. 1990 Dec;2(12):1D. No abstract available.
Fried PA The Ottawa Prenatal Prospective Study (OPPS): methodological issues and findings--it's easy to throw the baby out with the bath water. Life Sci. 1995;56(23-24):2159-68. doi: 10.1016/0024-3205(95)00203-i.
Grant TM, Graham JC, Carlini BH, Ernst CC, Brown NN Use of Marijuana and Other Substances Among Pregnant and Parenting Women With Substance Use Disorders: Changes in Washington State After Marijuana Legalization. J Stud Alcohol Drugs. 2018 Jan;79(1):88-95.
Grotenhermen F Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.
Hasin DS US Epidemiology of Cannabis Use and Associated Problems. Neuropsychopharmacology. 2018 Jan;43(1):195-212. doi: 10.1038/npp.2017.198. Epub 2017 Aug 30.
Huizink AC Prenatal cannabis exposure and infant outcomes: overview of studies. Prog Neuropsychopharmacol Biol Psychiatry. 2014 Jul 3;52:45-52. doi: 10.1016/j.pnpbp.2013.09.014. Epub 2013 Sep 27.
Ko JY, Tong VT, Bombard JM, Hayes DK, Davy J, Perham-Hester KA Marijuana use during and after pregnancy and association of prenatal use on birth outcomes: A population-based study. Drug Alcohol Depend. 2018 Jun 1;187:72-78. doi: 10.1016/j.drugalcdep.2018.02.017. Epub 2018 Mar 29.
McLemore GL, Richardson KA Data from three prospective longitudinal human cohorts of prenatal marijuana exposure and offspring outcomes from the fetal period through young adulthood. Data Brief. 2016 Oct 18;9:753-757. doi: 10.1016/j.dib.2016.10.005. eCollection 2016 Dec.
Szutorisz H, Hurd YL High times for cannabis: Epigenetic imprint and its legacy on brain and behavior. Neurosci Biobehav Rev. 2018 Feb;85:93-101. doi: 10.1016/j.neubiorev.2017.05.011. Epub 2017 May 12.
Trezza V, Cuomo V, Vanderschuren LJ Cannabis and the developing brain: insights from behavior. Eur J Pharmacol. 2008 May 13;585(2-3):441-52. doi: 10.1016/j.ejphar.2008.01.058. Epub 2008 Mar 18.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.