Injection (the drug is introduced directly into the bloodstream or into tissue).The most common routes of drug administration are:.The process by which the drug is released from its pharmaceutical form (e.g., capsule, tablet, suppository, etc.).Pharmacokinetics deals with drug absorption, distribution, metabolism, and excretion. Definition: legal classification of substances based on their abusive potential.Expanded access: an FDA program that grants use of an investigational drug or medical device for the treatment of a serious condition for which there is no comparable or satisfactory alternative treatment available.
#Nbme 19 allosteric activator trial#
Randomized control trial with a large number of patients with a specific disease ( ∼ 100–1000).Final confirmation of safety and evaluation of efficacy against placebo or the current standard of care.Moderate number of patients with a specific disease ( ∼ 10–100).Evaluation of efficacy, optimal dose range, and side effects (esp.Small number of healthy individuals or patients with a specific disease ( ∼ 15–30 ).Evaluation of the maximum tolerated dose.Evaluation of pharmacodynamic and pharmacokinetic properties of the drug, safety and toxicity.Small sample: consisting either healthy individuals or of population with a disease of interest ( ∼ 10–15).Only
Exploratory phase with no therapeutic or diagnostic intent with the aim of gaining insight on pharmacokinetics and pharmacodynamics.