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Pharmacokine,cs
Pamela Berilyn So, RPh, Msc
Pharmaceu,cals
Approved by the FDA
Ac,ve Ingredient
Dosage Form
Route of Administra,on
in vivo performance
Safety and Ecacy
Importance of Formula,on
Route: (oral, IV, subQ, transdermal, etc.)
Drug release: predictable and characterizable
Site of ac,on: drug concentra,on>MEC
Pharmacologic response
Bioavailability
A measure of systemic availability of a drug
The rate and extent to which a drug
reaches the systemic circula,on
Drug Animal/ Response
product Human
Therapeu,cally eec,ve
Toxic
Has no apparent eect at all.
Biopharmaceu,cs
The science that examines the
interrela,onship of the physicochemical
proper,es of the drug, the dosage form in
which the drug is given, and the route of
administra,on on the rate and extent of
systemic drug absorp9on.
Biopharmaceu,cs
Involves factors that influences:
(1) the stability of the drug within the
drug product (DP)
(2) the release of the drug from the DP
(3) the rate of dissolu9on/release of the drug
at the absorp9on site
(4) the systemic absorp,on of the drug
Biopharmaceu,cs
Scheme demonstra,ng the dynamic
rela,onship between the drug, the drug
product, and the pharmacologic eect.
Pharmacokine,cs
The science of the kine,cs of drug absorp,on,
distribu,on, and elimina,on (M+E)
Drug Disposi9on (D+E)
Pharmacokine,cs
Experimental approach
development of biologic
sampling techniques
analy,cal methods for the measurement of
drugs and metabolites
procedures that facilitate data
collec9on and manipula9on
Pharmacokine,cs
Theore9cal approach
development of pharmacokine,c
models that predict drug disposi9on
a[er drug
administra9on
Theore,cal approach
Sta,s,cal methods
Used for pharmacokine,c parameter
es9ma9on and data interpreta9on
ul,mately for the purpose of designing and
predic,ng op9mal dosing regimens.
Applied to pharmacokine,c models to
determine data error and structural model
devia9ons.
Classical Pharmacokine,cs
A study of theore9cal models focusing mostly
on model development and parameteriza,on.
Clinical Pharmacokine,cs
Applica,on of pharmacokine,c methods to
drug therapy
Involves a mul,disciplinary approach to
individually op,mized dosing strategies based
on the pa,ent's disease state and pa,ent-
specific considera,ons.
Clinical Pharmacokine,cs
During the drug development process, large
numbers of pa,ents are tested to determine
op,mum dosing regimens
May result in either a subtherapeu,c (drug
concentra,on<MEC) or toxic response (drug
concentra,ons>MTC )