Changes or clarifications made in writing to the original protocol.
A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial. A study protocol must be approved by an IRB before investigational drugs may be administered to humans.
The study of the form, function and interactions of all the proteins of a tissue or organism.
The totality of the proteins of an organism.
A molecule consisting of a chain of amino acids.Because of the variety of their building blocks, proteins can differ greatly in form and function.
A region of fiDNA immediately before a gene that contains the starting information for transcription of that gene.
Ancestor cells that can restore function in tissues damaged by disease. Progenitor cells found in the bone marrow, for instance, are stimulated by the recombinant protein erythropoietin to form mature red blood cells.
Before a drug may be tested on humans, pre-clinical studies must be conducted either in vitro but usually in vivo on animals to determine that the drug is safe.
A method of medicine investigation in which an inactive substance (the “placebo”) is given to one group of subjects, while the test medicine is given to another group. Results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.