Dodeja, Prerna
(2021)
Development and Validation of a Blood Micro sampling Methodology to facilitate Pharmacokinetic Studies in Pregnant and Postpartum Patients.
Master's Thesis, University of Pittsburgh.
(Unpublished)
This is the latest version of this item.
Abstract
Pregnancy is associated with several physiological changes that can alter the pharmacokinetics (PK) and necessitate dosing regimen changes for certain drugs in order to achieve drug exposures that are comparable to non-pregnant population. However, limited data is available in pregnant women in order to make rational drug dosing recommendations. Therefore, dosing recommendations for drugs, including treatment for opioid addiction, are usually extrapolated from studies carried out in non-pregnant patients. Among the reasons for lack of data is the difficulty associated with collection of multiple blood samples in opioid addicted pregnant women. Permanent damage caused to veins due to chronic IV drug use in these patients makes it especially challenging to obtain venous blood samples. Application of micro blood sampling as a tool for remote blood sampling can offer a convenient way for performing studies in this population. A novel micro blood sampling device called Volumetric Absorptive micro sampling (VAMS) developed in 2014 has resolved sample inhomogeneity issues inherent with previous dried blood Spot (DBS) techniques. The VAMS technique has also demonstrated improved precision in the volume of sample collected. Proper experimental design and optimization of the extraction of drugs and metabolites of interest are the key parameters in the application of a VAMS approach. Our study objective is to evaluate the utility of a micro sampling approach for self-collection of blood samples in order to monitor buprenorphine concentrations and to optimize the dosage of buprenorphine in pregnant and post-partum patients.
In this study, we have developed and validated an LC-MS/MS assay to measure Buprenorphine and attempted to quantify metabolites of the parent drug in whole blood samples simultaneously from the VAMS device, that can be of help in future studies in pregnant and postpartum subjects.
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Details
| Item Type: |
University of Pittsburgh ETD
|
| Status: |
Unpublished |
| Creators/Authors: |
|
| ETD Committee: |
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| Date: |
9 August 2021 |
| Date Type: |
Publication |
| Defense Date: |
16 April 2021 |
| Approval Date: |
9 August 2021 |
| Submission Date: |
22 May 2021 |
| Access Restriction: |
No restriction; Release the ETD for access worldwide immediately. |
| Number of Pages: |
88 |
| Institution: |
University of Pittsburgh |
| Schools and Programs: |
School of Pharmacy > Pharmaceutical Sciences |
| Degree: |
MS - Master of Science |
| Thesis Type: |
Master's Thesis |
| Refereed: |
Yes |
| Uncontrolled Keywords: |
micro sampling, Buprenorphine, pregnancy, pharmacokinetics, assay development, VAMS, Dried Blood Spots, Volumetric Absorptive Micro sampling |
| Date Deposited: |
09 Aug 2021 15:56 |
| Last Modified: |
09 Aug 2021 15:56 |
| URI: |
http://d-scholarship.pitt.edu/id/eprint/41137 |
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Development and Validation of a Blood Micro sampling Methodology to facilitate Pharmacokinetic Studies in Pregnant and Postpartum Patients. (deposited 09 Aug 2021 15:56)
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