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Article ; Online: Commentary on Unexpected Fentanyl Detection during a Liver Transplant Evaluation.

Pandya, Vrajesh

2023 Volume 69, Issue 3, Page(s) 226–227

MeSH term(s)	Humans ; Liver Transplantation ; Fentanyl/analysis
Chemical Substances	Fentanyl (UF599785JZ)
Language	English
Publishing date	2023-03-01
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1093/clinchem/hvad003
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Article ; Online: A Simple, Fast, and Reliable LC-MS/MS Method for the Measurement of Homovanillic Acid and Vanillylmandelic Acid in Urine Specimens.

Pandya, Vrajesh / Frank, Elizabeth L

Methods in molecular biology (Clifton, N.J.)

2022 Volume 2546, Page(s) 175–183

Abstract: Homovanillic acid (HVA) and vanillylmandelic acid (VMA) are catecholamine metabolites used in the diagnostic workup of neuroendocrine tumors. Here we describe a simple dilute-and-shoot method for simultaneously quantitating HVA and VMA in human urine ... ...

Abstract	Homovanillic acid (HVA) and vanillylmandelic acid (VMA) are catecholamine metabolites used in the diagnostic workup of neuroendocrine tumors. Here we describe a simple dilute-and-shoot method for simultaneously quantitating HVA and VMA in human urine specimens. The method employs analyte separation on a reverse-phase liquid chromatography column followed by detection using electrospray ionization triple quadrupole mass spectrometry (ESI-MS/MS), wherein qualifier and quantifier ion transitions are monitored. This is a simple and fast analytical method with an injection-to-injection time of 4 min.
MeSH term(s)	Catecholamines ; Chromatography, Liquid/methods ; Homovanillic Acid/chemistry ; Homovanillic Acid/urine ; Humans ; Tandem Mass Spectrometry/methods ; Vanilmandelic Acid/urine
Chemical Substances	Catecholamines ; Vanilmandelic Acid (55-10-7) ; Homovanillic Acid (X77S6GMS36)
Language	English
Publishing date	2022-09-20
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1940-6029
ISSN (online)	1940-6029
DOI	10.1007/978-1-0716-2565-1_16
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Article ; Online: Longitudinal trends in meconium drug detection in 46 US states between the years 2015 and 2020.

Pandya, Vrajesh / Wilker, Chase / Johnson-Davis, Kamisha L

Journal of analytical toxicology

2023 Volume 47, Issue 6, Page(s) 495–503

Abstract: Maternal drug use during pregnancy has significant health and socio-legal implications. The Substance Abuse and Mental Health Services Administration publishes self-reported rates of drug use during pregnancy; however, comprehensive long-term laboratory ... ...

Abstract	Maternal drug use during pregnancy has significant health and socio-legal implications. The Substance Abuse and Mental Health Services Administration publishes self-reported rates of drug use during pregnancy; however, comprehensive long-term laboratory data on neonatal drug exposure are lacking. Over 175,000 meconium specimens originating from 46 US states were analyzed at ARUP Laboratories between the years 2015 and 2020. A retrospective investigation of drug positivity rates, multidrug detection and median drug concentrations was conducted for 28 compounds in six drug classes. The overall meconium drug positivity rate was lowest in 2015 (47.3%), which increased over 6 years, reaching a peak in 2020 (53.4%). 11-Nor-9-carboxy-tetrahydrocannabinol (THC-COOH) was the most frequently detected compound across all 6 years. The second most frequently detected analyte was morphine in 2015-2016 and amphetamines in 2017-2020. The THC-COOH positivity rate rose from 29.7% in 2015 to 38.2% in 2020. The positivity rates for stimulants also increased in the range of 0.4-2.9% in 2020 compared to 2015. Conversely, opioid positivity rates declined in the range of 1.6-2.3% in 2020 as compared to 2015. The most common two-drug combination was THC-COOH-opioids (2.4%) in 2015-2016, which was replaced by THC-COOH-amphetamines (2.6%) in 2017-2020. The most common three-drug combination was THC-COOH-opioids-amphetamines throughout all 6 years. Neonatal drug exposure positivity rates have increased over the past 6 years based on retrospective data analysis from the patient population submitted for testing at ARUP Laboratories.
MeSH term(s)	Infant, Newborn ; Pregnancy ; Female ; Humans ; Meconium/chemistry ; Analgesics, Opioid/analysis ; Retrospective Studies ; Gas Chromatography-Mass Spectrometry ; Substance Abuse Detection ; Dronabinol/analysis ; Amphetamines/analysis
Chemical Substances	Analgesics, Opioid ; Dronabinol (7J8897W37S) ; Amphetamines
Language	English
Publishing date	2023-04-18
Publishing country	England
Document type	Journal Article
ZDB-ID	752391-9
ISSN	1945-2403 ; 0146-4760
ISSN (online)	1945-2403
ISSN	0146-4760
DOI	10.1093/jat/bkad024
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Article: Deceptively Simple: Can Urine Samples from CLIA-Waived Urine Drug Screen Devices Be Reused for Confirmatory Testing?

Pandya, Vrajesh / McMillin, Gwendolyn A / Young, Brittany A

The journal of applied laboratory medicine

2022 Volume 8, Issue 2, Page(s) 341–346

Abstract: Background: Many low-complexity urine drug screen (UDS) devices are approved by the Food and Drug Administration as waived under Clinical Laboratory Improvement Amendments (CLIA) criteria. Labeling instructs patients to urinate directly into the device ... ...

Abstract	Background: Many low-complexity urine drug screen (UDS) devices are approved by the Food and Drug Administration as waived under Clinical Laboratory Improvement Amendments (CLIA) criteria. Labeling instructs patients to urinate directly into the device and also states that positive results should be confirmed. However, the device itself may pose a risk of drug adsorption and/or specimen contamination that could affect results in confirmatory assays if specimens are reused. Collecting urine in a separate container before performing the UDS would reclassify the test as nonwaived, negating the conveniences of a CLIA-waived test. Also, patients may be unable or unwilling to urinate in an additional container for confirmatory testing. This study examined reusing urine from a UDS device (NexScreen) for confirmatory testing. Methods: 25 patient specimens were pooled and verified to be drug-free. To evaluate drug leaching from the UDS device, 30 mL of this pool was incubated in NexScreen cups, followed by confirmatory testing. To evaluate drug adsorption, 14 representative analytes were spiked slightly over the NexScreen positivity cutoffs, followed by incubation in NexScreen cups and confirmation testing. Results: All negative samples incubated in NexScreen cups remained negative upon confirmation testing, indicating that NexScreen test strips do not contaminate the specimen. For the drug adsorption experiment, 11 of 14 analytes had recoveries of at least 95%, whereas buprenorphine and 11-nor-9-carboxy-tetrahydrocannabinol recovered at 94% and 87%, respectively, suggesting minor adsorption. All analytes recovered above their respective confirmation cutoffs. Conclusions: Urine aliquots from NexScreen cups may be used for confirmatory testing.
MeSH term(s)	United States ; Humans ; Laboratories, Clinical ; Clinical Laboratory Services ; Laboratories ; Biological Assay ; Dronabinol
Chemical Substances	Dronabinol (7J8897W37S)
Language	English
Publishing date	2022-11-14
Publishing country	England
Document type	Journal Article
ISSN	2576-9456
ISSN	2576-9456
DOI	10.1093/jalm/jfac094
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Article ; Online: Can Umbilical Cord and Meconium Results Be Directly Compared? Analytical Approach Matters.

Pandya, Vrajesh / Wilker, Chase / McMillin, Gwendolyn A

Journal of analytical toxicology

2022 Volume 47, Issue 1, Page(s) 96–105

Abstract: Maternal drug use during pregnancy is a significant concern. Drug-exposed newborns are often born premature and may suffer from birth defects, neonatal abstinence syndrome and cognitive and developmental delays. Because of this, testing of neonatal ... ...

Abstract	Maternal drug use during pregnancy is a significant concern. Drug-exposed newborns are often born premature and may suffer from birth defects, neonatal abstinence syndrome and cognitive and developmental delays. Because of this, testing of neonatal specimens is carried out to assess fetal drug exposure during pregnancy. Umbilical cord tissue (UC) and meconium are commonly used specimens for this purpose. However, comprehensive studies comparing drug positivity rates and concentration in the two specimen types are lacking. To this end, 4,036 paired UC and meconium specimens originating from 13 states within the USA were identified, and retrospective analysis of drug positivity rates and drug concentration was performed for 31 analytes in 5 drug classes. Testing for 11-Nor-9-carboxy-tetrahydrocannabinol (THC-COOH) is a separate orderable for UC specimen at our laboratory, so a second data set was created for evaluation of this drug analyte with 2,112 paired UC and meconium specimens originating from 11 states. Testing of UC was performed by semi-quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) assays, whereas, for meconium, an immunoassay-based screening preceded LC-MS-MS confirmation tests. Results generated for UC and meconium specimens were therefore compared for a total of 32 drug analytes from 6 drug classes. Drug concentrations for analytes were higher in meconium compared to UC, with the exception of phencyclidine. Despite this, the positivity rates for individual analytes were higher in UC, with the exception of THC-COOH and cocaine. Furthermore, analysis for multidrug positivity revealed that THC-COOH and opioids were the most common multidrug combination detected in both matrices. In conclusion, this study suggests that for most drug compounds, UC was more analytically sensitive to assess neonatal drug exposure by current methodologies. Additionally, by demonstrating that meconium has higher drug concentrations for most compounds, this study sets the stage for developing more sensitive assays in meconium.
MeSH term(s)	Infant, Newborn ; Pregnancy ; Humans ; Female ; Meconium/chemistry ; Retrospective Studies ; Substance Abuse Detection/methods ; Cocaine/analysis ; Umbilical Cord
Chemical Substances	Cocaine (I5Y540LHVR)
Language	English
Publishing date	2022-05-26
Publishing country	England
Document type	Journal Article
ZDB-ID	752391-9
ISSN	1945-2403 ; 0146-4760
ISSN (online)	1945-2403
ISSN	0146-4760
DOI	10.1093/jat/bkac037
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Article ; Online: Detection of a High-Dose Hook Effect and Evaluation of Dilutions of Urine Myoglobin Specimens Using a Serum Myoglobin Assay.

Hunsaker, Joshua Joon Hyung / La'ulu, Sonia Leilani / Zupan, Emily / Patel, Dhwani / Pandya, Vrajesh / Rudolf, Joseph William

Annals of laboratory medicine

2024 Volume 44, Issue 4, Page(s) 367–370

MeSH term(s)	Humans ; Myoglobin/analysis ; Urinalysis
Chemical Substances	Myoglobin
Language	English
Publishing date	2024-03-14
Publishing country	Korea (South)
Document type	Letter
ZDB-ID	2677441-0
ISSN	2234-3814 ; 2234-3814
ISSN (online)	2234-3814
ISSN	2234-3814
DOI	10.3343/alm.2023.0427
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Article ; Online: Spirited away: Can ethanol testing in add-on orders provide meaningful results?

Pandya, Vrajesh / Nguyen Sorenson, Anh H T / Jones, Erin / Young, Brittany A / Pearson, Lauren N

Clinical biochemistry

2022 Volume 115, Page(s) 97–102

Abstract: Ethanol is a volatile substance, and specimens need to be tightly capped prior to analysis to prevent evaporative loss. However, add-on requests in previously decapped tubes are commonly received, yet ethanol stability in this setting is unclear. We ... ...

Abstract	Ethanol is a volatile substance, and specimens need to be tightly capped prior to analysis to prevent evaporative loss. However, add-on requests in previously decapped tubes are commonly received, yet ethanol stability in this setting is unclear. We compared the stability of ethanol in capped vs decapped tubes in the context of routine laboratory automation, storage time, and specimen volumes. Serum specimens were pooled and spiked with ethanol followed by simulating an add-on scenario. Additionally, to evaluate ethanol stability at room temperature for extended times, ethanol concentrations were measured in capped or decapped tubes containing 0.5 mL or 0.1 mL samples over a 4 h time course. Finally, the risk of misclassification of ethanol results in decapped tubes was evaluated near the critical value threshold (∼54 mmol/L). The add-on tubes had a mean recovery of 101.5 % (95 % CI: 97.7-105.4 %) relative to the direct tubes. The time-course experiment showed an average recovery of 87.4 % (95 % CI: 81.8-94.0 %) at the 4 h time point in decapped 0.5 mL specimens. An average recovery of 85.4 % (95 % CI: 84.2-86.1 %) was observed for specimens spiked near the critical value threshold. Importantly, all measurements with 0.5 mL specimen volume were within 25 %, which is the total allowable error (TAE) of the assay.However, with a 0.1 mL volume, specimens cross the TAE threshold just after 1 h, and the percent recovery at 4 h dropped to 52.9 % (95 % CI: 50.2-55.7 %). In conclusion, ethanol testing in decapped tubes remains within the TAE for up to 4 h in specimens with a 0.5 mL volume. Therefore, add-on ethanol testing using routine laboratory automation and storage conditions can be successfully performed.
MeSH term(s)	Humans ; Ethanol ; Time Factors ; Blood Coagulation Tests
Chemical Substances	Ethanol (3K9958V90M)
Language	English
Publishing date	2022-11-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	390372-2
ISSN	1873-2933 ; 0009-9120
ISSN (online)	1873-2933
ISSN	0009-9120
DOI	10.1016/j.clinbiochem.2022.11.001
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Article ; Online: How I Evaluate a High Anion Gap Metabolic Acidosis.

Azim, Aniqa / Hu, Boyu / Gilligan, Sarah / Sarwal, Amara / Hartsell, Sydney / Pandya, Vrajesh / Raphael, Kalani L

Clinical journal of the American Society of Nephrology : CJASN

2023 Volume 19, Issue 4, Page(s) 525–527

MeSH term(s)	Humans ; Acid-Base Equilibrium ; Acidosis/diagnosis ; Acidosis/etiology
Language	English
Publishing date	2023-11-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2226665-3
ISSN	1555-905X ; 1555-9041
ISSN (online)	1555-905X
ISSN	1555-9041
DOI	10.2215/CJN.0000000000000381
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Article ; Online: Nonclinical Pharmacokinetic Evaluation of Desidustat: a Novel Prolyl Hydroxylase Inhibitor for the Treatment of Anemia.

Patel, Harilal / Modi, Nirav / Chaudhari, Jaimin / Patel, Prakash / Giri, Poonam / Patel, Hiren / Pandya, Vrajesh / Desai, Ranjit / Jain, Mukul

European journal of drug metabolism and pharmacokinetics

2022 Volume 47, Issue 5, Page(s) 725–740

Abstract: Background and objectives: Desidustat is a novel prolyl hydroxylase domain (PHD) inhibitor for the treatment of anemia. The objective of this study was to investigate the pharmacokinetics and drug-drug interaction properties of desidustat using in vitro ...

Abstract	Background and objectives: Desidustat is a novel prolyl hydroxylase domain (PHD) inhibitor for the treatment of anemia. The objective of this study was to investigate the pharmacokinetics and drug-drug interaction properties of desidustat using in vitro and in vivo nonclinical models. Methods: In vitro, Caco2 cell permeability, plasma protein binding, metabolism, cytochrome P450 (CYP) inhibition, and CYP induction were examined. In vivo, pharmacokinetic studies of oral bioavailability in mice, rats, dogs and monkeys, dose linearity, tissue distribution, and excretion in rats were conducted. Results: In Caco-2 cells, the apparent permeability of desidustat was high at low pH and low at neutral pH. The oral bioavailability (%F) of desidustat was 43-100% with a median time to reach peak concentration (T Conclusion: Taken together, desidustat is well absorbed orally. It showed a dose-dependent increase in exposure, did not accumulate in tissue, and was eliminated via dual routes. It is metabolically stable, has minimal potential to cause clinical drug-drug interactions (DDIs), and demonstrates discriminable pharmacokinetic properties for the treatment of anemia.
MeSH term(s)	Administration, Oral ; Anemia/metabolism ; Animals ; Caco-2 Cells ; Cytochrome P-450 Enzyme System/metabolism ; Dogs ; Humans ; Mice ; Microsomes, Liver/metabolism ; Prolyl-Hydroxylase Inhibitors/pharmacology ; Quinolones ; Rats
Chemical Substances	Prolyl-Hydroxylase Inhibitors ; Quinolones ; Cytochrome P-450 Enzyme System (9035-51-2) ; desidustat (Y962PQA4KS)
Language	English
Publishing date	2022-07-26
Publishing country	France
Document type	Journal Article
ZDB-ID	196729-0
ISSN	2107-0180 ; 0398-7639 ; 0378-7966
ISSN (online)	2107-0180
ISSN	0398-7639 ; 0378-7966
DOI	10.1007/s13318-022-00788-3
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Article ; Online: Combating Autoimmune Diseases With Retinoic Acid Receptor-Related Orphan Receptor-γ (RORγ or RORc) Inhibitors: Hits and Misses.

Pandya, Vrajesh B / Kumar, Sanjay / Sachchidanand / Sharma, Rajiv / Desai, Ranjit C

Journal of medicinal chemistry

2018 Volume 61, Issue 24, Page(s) 10976–10995

Abstract: The nuclear receptor retinoic acid receptor-related orphan receptor gamma (RORγ or RORc) is a key transcription factor for the production of pro-inflammatory cytokines implicated in the pathogenesis of autoimmune diseases. Recently, small molecule ... ...

Abstract	The nuclear receptor retinoic acid receptor-related orphan receptor gamma (RORγ or RORc) is a key transcription factor for the production of pro-inflammatory cytokines implicated in the pathogenesis of autoimmune diseases. Recently, small molecule inhibitors of RORc drew the enormous attention of the research community worldwide as a possible therapy for autoimmune diseases, mediated by the IL-17 cytokine. With the clinical proof-of-concept inferred from a small molecule inhibitor VTP-43742 for psoriasis and recent inflow of several RORc inhibitors into the clinic for therapeutic interventions in autoimmune diseases, this field continues to evolve. This review briefly summarizes the RORc inhibitors disclosed in the literature and discusses the progress made by these inhibitors in combating autoimmune diseases.
MeSH term(s)	Amides/chemistry ; Amides/pharmacology ; Autoimmune Diseases/drug therapy ; Clinical Trials as Topic ; Humans ; Nuclear Receptor Subfamily 1, Group F, Member 3/antagonists & inhibitors ; Nuclear Receptor Subfamily 1, Group F, Member 3/chemistry ; Pyridines/chemistry ; Pyridines/pharmacology ; Pyrrolidines/chemistry ; Pyrrolidines/pharmacology ; Sulfonamides/chemistry ; Sulfonamides/pharmacology
Chemical Substances	Amides ; Nuclear Receptor Subfamily 1, Group F, Member 3 ; Pyridines ; Pyrrolidines ; RORC protein, human ; Sulfonamides ; VTP-43742
Language	English
Publishing date	2018-07-30
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	218133-2
ISSN	1520-4804 ; 0022-2623
ISSN (online)	1520-4804
ISSN	0022-2623
DOI	10.1021/acs.jmedchem.8b00588
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