Laboratory Procedures in TDM for Pharma 204 Lab by Dr Agaid.pdf

short discourse on therapeutic drug monitoring

2. 1 Baktır, G. (2017). THERAPEUTIC DRUG MONITORING (TDM). Lectio Scientific, 1(1), 54-65.

3. 1. Trends in Biotechnology, November 2020, Vol. 38, No. 11 https://doi.org/10.1016/j.tibtech.2020.03.001

4. Narrow
therapeutic range
Pharmacokinetic
variability
Reasonable
relationship b/n
concentrations &
clinical effects
Established target
concentration
range
Availability of cost-
effective drug
assay
When the risk of
poor compliance is
high
When low
concentration
increases the risk
of resistance
2 Baktır G. THERAPEUTIC DRUG MONITORING (TDM). LectioSc. May 2017;1(1):54-65.

5. Measuring plasma
drug concentration
(PDC)
Monitoring
overdose
Reduce toxicity
Monitor drug levels
to identify the
clinical output of
active metabolites
Drug-drug
interaction

7. 4 Br J Clin Pharmacol.2001 Sep; 52(Suppl 1): 5S–10S. doi:10.1046/j.1365-2125.2001.0520s1005.x
•TDM indications
Decision to
request drug level
• Collection at steady
state except with
those long HL
•Serum or plasma,
capillary blood
Biological Sample
•Patient
demographics
The request

8. 4 Br J Clin Pharmacol.2001 Sep; 52(Suppl 1): 5S–10S. doi:10.1046/j.1365-2125.2001.0520s1005.x
•Quality drug assay
•Accredited analytical laboratory
•Turn around time
•Commercial kits, HPLC, FPIA, EMIT,
ELISA –chromatpgraphy, mass
spectrometry, immunoassays Laboratory
Measurement
• Details
•Analytic technique
•In Molar or Mass units
(preferred)
Result
communication •Consider clinical response,
demographics, clinical status,
dosage regimen, indication of
TDM, pharmacokinetic
•Consultation with TDM team if
available
Clinical
Interpretation
•Modification of drug
dosage regimen
Therapeutic
Management

9. Pharmacogenomics (PGx)
•Personalized medicine
•Use of genetic info to
guide drug therapy ie
cetuximab, dasatinib,
maraviroc,
trastuzumab
5
•GWAS vis a vis precision
medicine
Point of Care (POC)
Testing for TDM
•Allowed faster TDM
results
•IePOCT for
immunosuppressive
drugs (ISD)
6
Nanotechnology in TDM
• Focused on biosensors
and Miniaturization7
5 Zhang C, Lei J, Liu Y, Wang Y, Huang L and Feng Y (2021) Therapeutic Drug Monitoring and Pharmacogenetic Testing in Northern China.Front. Pharmacol.12:754380. doi:
10.3389/fphar.2021.754380
6 Adriano Taddeo, Denis Prim, Elena-Diana Bojescu, Jean-Manuel Segura, Marc E Pfeifer, Point-of-Care Therapeutic Drug Monitoring for Precision Dosing of Immunosuppressive
Drugs, The Journal of Applied Laboratory Medicine, Volume 5, Issue 4, July 2020, Pages 738–761, https://doi.org/10.1093/jalm/jfaa067
7 Adriano Taddeo, Denis Prim, Elena-Diana Bojescu, Jean-Manuel Segura, Marc E Pfeifer, Point-of-Care Therapeutic Drug Monitoring for Precision Dosing of Immunosuppressive
Drugs, The Journal of Applied Laboratory Medicine, Volume 5, Issue 4, July 2020, Pages 738–761, https://doi.org/10.1093/jalm/jfaa067

10. 1.Baktır, G. (2017). THERAPEUTIC DRUG MONITORING (TDM). Lectio Scientific, 1(1), 54-65.
2.Ravinandan AP., et al. “Therapeutic Drug Monitoring and Its Analytical Methods - An Educational Review”. Medicon Medical Sciences 4.1
(2023): 03-08.
3.3Kang JS, Lee MH. Overview of therapeutic drug monitoring. Korean J Intern Med. 2009 Mar;24(1):1-10. doi: 10.3904/kjim.2009.24.1.1.
PMID: 19270474; PMCID: PMC2687654.
4.Trends in Biotechnology, November 2020, Vol. 38, No. 11 https://doi.org/10.1016/j.tibtech.2020.03.001
5.4 Br J Clin Pharmacol.2001 Sep; 52(Suppl 1): 5S–10S. doi:10.1046/j.1365-2125.2001.0520s1005.x
6.Zhang C, Lei J, Liu Y, Wang Y, Huang L and Feng Y (2021) Therapeutic Drug Monitoring and Pharmacogenetic Testing in Northern
China.Front. Pharmacol.12:754380. doi: 10.3389/fphar.2021.754380
7.Adriano Taddeo, Denis Prim, Elena-Diana Bojescu, Jean-Manuel Segura, Marc E Pfeifer, Point-of-Care Therapeutic Drug Monitoring for
Precision Dosing of Immunosuppressive Drugs, The Journal of Applied Laboratory Medicine, Volume 5, Issue 4, July 2020, Pages 738–
761, https://doi.org/10.1093/jalm/jfaa067
8. Adriano Taddeo, Denis Prim, Elena-Diana Bojescu, Jean-Manuel Segura, Marc E Pfeifer, Point-of-Care Therapeutic Drug Monitoring for
Precision Dosing of Immunosuppressive Drugs, The Journal of Applied Laboratory Medicine, Volume 5, Issue 4, July 2020, Pages 738–
761, https://doi.org/10.1093/jalm/jfaa067