Adherence, Patient — Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM (Trademark) in Normal Humans
Citation(s)
Geppert J, Demmelmair H, Hornstra G, Koletzko B Co-supplementation of healthy women with fish oil and evening primrose oil increases plasma docosahexaenoic acid, gamma-linolenic acid and dihomo-gamma-linolenic acid levels without reducing arachidonic acid concentrations. Br J Nutr. 2008 Feb;99(2):360-9. doi: 10.1017/S0007114507801577. Epub 2007 Aug 3.
Goddard-Borger ED, Williams SJ Sulfoquinovose in the biosphere: occurrence, metabolism and functions. Biochem J. 2017 Feb 20;474(5):827-849. doi: 10.1042/BCJ20160508.
Martens-Lobenhoffer J, Meyer FP Pharmacokinetic data of gamma-linolenic acid in healthy volunteers after the administration of evening primrose oil (Epogam). Int J Clin Pharmacol Ther. 1998 Jul;36(7):363-6.
Mills, J S.; Mills, G. C.; Mcadoo, D. J. Isolation and identification of 5'-methylthioadenosine sulfoxide from human urine. Nucleosides and Nucleotides 1983, 2 (5), 465-478.
Tahvonen RL, Schwab US, Linderborg KM, Mykkanen HM, Kallio HP Black currant seed oil and fish oil supplements differ in their effects on fatty acid profiles of plasma lipids, and concentrations of serum total and lipoprotein lipids, plasma glucose and insulin. J Nutr Biochem. 2005 Jun;16(6):353-9. doi: 10.1016/j.jnutbio.2005.01.004.
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.
