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I am very impressed by your discussions in the Pharm PK forum and your
responses are highly interesting and thought provoking.
Briefly, Allow me to introduce myself as Mr. Santosh Tata Presently
working as a Scientist in the Bioanalytical Laboratory of Clinsys in
India. On the job, I conduct Method Development, Validation and
Routine sample analysis for BA/BE studies using LC-MS/MS. During my
previous and current assignments, I am acquinted with projects related
to Pharmacokinetics, Bioequivalence, evaluation of dosage form effect
I have developed tremendous interest in the areas Pop PK and its
application to Dose optimization.
As a novice to this field of PK/PD integration I require your help and
guidance. I have some questions reg a thought project for which I
require your guidance.
Objective: To verify whether a given antibiotic is marketed with the
right dose for different age groups.
Briefly, the experiment goes like this:
1. Invitro MIC concentrations of the test drug shall be determined
using a disc-plate method or the cup plate method.
2. the same test drug shall be administered to different groups of
animals at different doses.
3. the Pharmacokinetics shall be observed using a validated method.
4. dose effect on Pharmacokinetics is obtained.
5. IVIVC is plotted.
6. Pharmacodynamics & disease progression shall be monitored using a
Now data is obtained.
After the above experiments are done, How should I proceed further to
realize my objective of the project?
are there any biomarkers to determine disease progression??. What
other data are required??. Are there any special tools for data
I am aware LDL is a good biomarker for Statin drugs, glucose for anti-
diabetics. what about biomarkers for gastric ulcer??
I wanted to limit my experiment to preclinical subjects and then take
available data on humans from literature. Then I want to extrapolate
the data from preclinical to clinical applications. By this process I
want to verify the objective of my project. I am not sure whether my
thoughts are in the right direction to realize this project.
Please enlighten me on this area. I am sure I am approaching the right
person. Additionally please write to me regarding the feasibility of
Anticipating your valuble suggestions,
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One way is to plot Pk PD data this may help you to understand the dose.
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