Clinical Trials - Phase -I
Single Ascending Dose studies ( SAD )
In single Ascending dose studies small groups of patients consisting of 3 to 6 people are given small doses of the drug to be tested and are then observed for as specific period of time . If these patients do not develop any side effects during the period of observation, a higher dosage of the same drug is tried out on a new group of individuals. This process continues until intolerable side effects start showing up, this stage denotes the Maximum Tolerated Dose ( MTD) of the drug .
Multiple Ascending Dose studies ( MAD )
In Multiple Ascending Dose studies are done in order to get a better understanding of the pharmacokinetics / pharmacodynamics of a new drug or treatment. The participants receive various doses of the drug ranging from the lowest dose upto a predetermined level. Simutaenously samples of blood and other body fluids are taken each time the dose of the drug is raised and it is analyzed in order to understand how the drug is tolerated by the body .