Oral Administration of Drug> plasma/protein complex, adipose tissue, effector tissue, peripheral tissues via metabolism, Liver( –>bile), Kidney…
Liver is a big defense of the body, it metabolizes most of the drugs (Cyps).
It refers to the relationship between drug concentration at the site of action and pharmacological response, i.e., the intensity and time course of therapeutic and adverse effects.
The study of physiological effects of drugs and their mechanism of action
How drugs move around the body?
How quickly this movement occurs?
The study of the time course of drug *Absorption (except for the IV route), Distribution, Metabolism and Excretion (ADME).*
Understand *slide 11*
From Fadi’s lecture on FDA trial process…
Discovery phase or Animal testing –>the to P1(stability) –>P2 (efficacy)–> P3 (efficacy)
*stability is the most important*
Analytical methods need to be ________
Sensitive assay can measure drug at low concentrations.
Specific assay can distinguish drug from other interference.
Precise assay can provide accuracy and reproducibility.
HPLC/MS (mass spectrometry) and LC/MS/MS
Gas chromatography (GC)
Enzyme multiplied immunoassay
Many of the processes involved in drug movement around the body are
To assess the relationship between drug concentration and pharmacological activities. This helps to understand magnitude of therapeutic and toxic responses at different dosage levels.
To establish bioequivalence i.e., to check whether different formulations will produce the same plasma drug concentrations or not, and therefore will produce similar therapeutic effects.
It involves a multidisciplinary approach to *individually optimized dosing strategies* based on the patient’s disease state and patient-specific considerations.
Between these limits of concentration lies a region associated with therapeutic success; this region is regarded as _______.
TDM is essential for drugs with narrow therapeutic widow such as *phenytoin, digoxin, lidocaine, theophilline.*