da Silva OP, Knoppert DC, Angelini MM, Forret PA Effect of domperidone on milk production in mothers of premature newborns: a randomized, double-blind, placebo-controlled trial. CMAJ. 2001 Jan 9;164(1):17-21.
Giugliani ER [Breast-feeding in clinical practice]. J Pediatr (Rio J). 2000 Nov;76 Suppl 3:S238-52. Portuguese.
Wan EW, Davey K, Page-Sharp M, Hartmann PE, Simmer K, Ilett KF Dose-effect study of domperidone as a galactagogue in preterm mothers with insufficient milk supply, and its transfer into milk. Br J Clin Pharmacol. 2008 Aug;66(2):283-9. doi: 10.1111/j.1365-2125.2008.03207.x. Epub 2008 Apr 21.
Zavitsanos AP, MacDonald C, Bassoo E, Gopaul D Determination of domperidone in human serum and human breast milk by high-performance liquid chromatography-electrospray mass spectrometry. J Chromatogr B Biomed Sci Appl. 1999 Jun 25;730(1):9-24.
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.
