MULTIPLE ASCENDING DOSE STUDIES (MAD) ::
They are conducted to better understand the pharmacokinetics & pharmacodynamics of multiple dose of the drug in these studies a group of patients receives multiple low doses of the drug whilst samples (of blood and other fluids ) are collected at various time points and analyzed to understand how the drug is processed within the body The dose is subsequently escalated for further groups up to a predetermined level
FOOD EFFECT ::
It is a short trial designed to investigate any differences in absorption caused by eating pre-dose and its effect on the pharmacokinetic profile These studies are usually run as a cross over study with volunteers given two identical doses of the drug on different occasions one while fasted and one after being fed
The prime requisite for such studies are pointed diagnosis and uniformity of patient with respect to age sex weight and severity of the disease as well as sensitivity of the patient
The first dose which is to be administered is usually 1/6th to 1/8th of the predicted effective dose once this minimum dose is tolerated the dose is increased gradually to establish the maximum it at which dose has greater effect but devoid of toxicity or the undesirable side effect No individual is exposed to more than single dose in a short period of time and a rest period of at least one week interval is given to prevent the cumulative effect if other known drugs are also to be administered it is necessary to watch for the abnormal reaction if any
These trials are almost always conducted in an inpatient clinic where the subject can be observed by full -time medical staff The bioavailability and bioequivalence studies are also considered to be the phase 1 study The subject is usually observed until several half -lives of the drug have passed
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