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European Medicines Agency Guideline on Bioanalytical Method Validation: What More Is There to Say?
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What this work says
Outgoing claims: the papers this work cites, builds on, or argues with.
inferredcites →https://doi.org/10.1208/aapsj0901004openalex-snapshot
Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
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Determination of carryover and contamination for mass spectrometry-based chromatographic assays
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Blood Stability Testing: European Bioanalysis Forum View on Current Challenges for Regulated Bioanalysis
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inferred← citeshttps://doi.org/10.1021/acschemneuro.3c00824openalex-snapshot
Simultaneous Determination of Selected Steroids with Neuroactive Effects in Human Serum by Ultrahigh-Performance Liquid Chromatography–Tandem Mass Spectrometry
inferred← citeshttps://doi.org/10.1021/acsomega.0c03874openalex-snapshot
A Validated Method for Quantification of Fatty Acids Incorporated in Human Plasma Phospholipids by Gas Chromatography–Triple Quadrupole Mass Spectrometry
inferred← citeshttps://doi.org/10.1021/acsomega.3c04814openalex-snapshot
A Simple UPLC-MS/MS Assay of Rifampin in a Small Volume of Human Plasma
inferred← citeshttps://doi.org/10.1038/s41598-018-22206-yopenalex-snapshot
Risk assessment of deoxynivalenol in high-risk area of China by human biomonitoring using an improved high throughput UPLC-MS/MS method
inferred← citeshttps://doi.org/10.1038/s41598-019-40928-5openalex-snapshot
UHPLC-MS/MS method for analysis of sobuzoxane, its active form ICRF-154 and metabolite EDTA-diamide and its application to bioactivation study
inferred← citeshttps://doi.org/10.1038/s41598-019-44240-0openalex-snapshot
Classification and Temporal Variability in Urinary 8-oxodG and 8-oxoGuo: Analysis by UHPLC-MS/MS
inferred← citeshttps://doi.org/10.1038/s41598-019-53093-6openalex-snapshot
Pharmacokinetics of Micafungin in Critically Ill Patients
inferred← citeshttps://doi.org/10.1038/s41598-020-60426-3openalex-snapshot
Determination of Kaurenoic Acid in Acanthopanax trifoliatus by Ultra-High Performance Liquid Chromatography Coupled with Tandem Mass Spectrometry (UHPLC-MS/MS)
inferred← citeshttps://doi.org/10.1038/s41598-021-81479-yopenalex-snapshot
Quantification of serum C-mannosyl tryptophan by novel assay to evaluate renal function and vascular complications in patients with type 2 diabetes
inferred← citeshttps://doi.org/10.1038/s41598-021-83688-xopenalex-snapshot
Development of water-soluble prodrugs of the bisdioxopiperazine topoisomerase IIβ inhibitor ICRF-193 as potential cardioprotective agents against anthracycline cardiotoxicity
inferred← citeshttps://doi.org/10.1038/s41598-021-89671-wopenalex-snapshot
In-vitro and in-vivo metabolism of different aspirin formulations studied by a validated liquid chromatography tandem mass spectrometry method
inferred← citeshttps://doi.org/10.1038/s41598-021-92915-4openalex-snapshot
Mining chemical information in Swedish wastewaters for simultaneous assessment of population consumption, treatment efficiency and environmental discharge of illicit drugs
inferred← citeshttps://doi.org/10.1038/s41598-024-71413-3openalex-snapshot
UPLC-PDA factorial design assisted method for simultaneous determination of oseltamivir, dexamethasone, and remdesivir in human plasma
inferred← citeshttps://doi.org/10.1039/c8ra03379jopenalex-snapshot
Pre-clinical pharmacokinetic-pharmacodynamic modelling and biodistribution studies of donepezil hydrochloride by a validated HPLC method
inferred← citeshttps://doi.org/10.1039/d1an01047fopenalex-snapshot
Overview, consequences, and strategies for overcoming matrix effects in LC-MS analysis: a critical review
inferred← citeshttps://doi.org/10.1039/d2ay01800dopenalex-snapshot
Development of a sensitive biochemical assay for the detection of tofacitinib adherence
inferred← citeshttps://doi.org/10.1049/enb2.12034openalex-snapshot
A decade of translational engineering biology: Measuring success
inferred← citeshttps://doi.org/10.1051/parasite/2021014openalex-snapshot
Pharmacokinetics of a novel endectoparasiticide topical formulation for cats, combining esafoxolaner, eprinomectin and praziquantel
inferred← citeshttps://doi.org/10.1080/00032719.2022.2092124openalex-snapshot
Simultaneous Determination of Steroids and Glucocorticoids in Human Urine by Ultra-High-Performance Liquid Chromatography – Tandem Mass Spectrometry (UPLC–MS/MS)
inferred← citeshttps://doi.org/10.1080/10717544.2019.1650849openalex-snapshot
Intraocular administration of tetramethylpyrazine hydrochloride to rats: a direct delivery pathway for brain targeting?
inferred← citeshttps://doi.org/10.1080/14992027.2019.1690170openalex-snapshot
Pharmacokinetics and other risk factors for kanamycin-induced hearing loss in patients with multi-drug resistant tuberculosis
inferred← citeshttps://doi.org/10.1080/15321819.2025.2603249openalex-snapshot
Forensic significance of ELISA technique for hormone assessment: a comprehensive review
inferred← citeshttps://doi.org/10.1080/17576180.2024.2344345openalex-snapshot
An LC-MS/MS method for the determination of Lifitegrast in human plasma and tear and its application in the pharmacokinetic study
inferred← citeshttps://doi.org/10.1080/17576180.2025.2489917openalex-snapshot
Bioanalysis of antihypertensive drugs by LC-MS: a fleeting look at the regulatory guidelines and artificial intelligence
inferred← citeshttps://doi.org/10.1080/19420862.2019.1658492openalex-snapshot
High sensitivity LC-MS profiling of antibody-drug conjugates with difluoroacetic acid ion pairing
inferred← citeshttps://doi.org/10.1080/19420862.2020.1795492openalex-snapshot
Development and validation of an LC-MS/MS method for simultaneous quantification of co-administered trastuzumab and pertuzumab
inferred← citeshttps://doi.org/10.1080/19420862.2021.1994690openalex-snapshot
Nonclinical safety evaluation, pharmacokinetics, and target engagement of Lu AF82422, a monoclonal IgG1 antibody against alpha-synuclein in development for treatment of synucleinopathies
inferred← citeshttps://doi.org/10.1093/cid/ciab665openalex-snapshot
Pharmacokinetics and Safety of 3 Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women
inferred← citeshttps://doi.org/10.1093/jat/bkad025openalex-snapshot
Intralipid as a matrix additive for evaluating hyperlipidemic postmortem blood
inferred← citeshttps://doi.org/10.1097/ftd.0000000000000632openalex-snapshot
Interlaboratory Analysis of Isavuconazole Plasma Concentration Assays Among European Laboratories
inferred← citeshttps://doi.org/10.1097/ftd.0000000000000833openalex-snapshot
Quantitation of Tacrolimus in Human Whole Blood Samples Using the MITRA Microsampling Device
inferred← citeshttps://doi.org/10.1097/inf.0000000000003055openalex-snapshot
Pharmacokinetics and Safety of Zidovudine, Lamivudine, and Lopinavir/Ritonavir in HIV-infected Children With Severe Acute Malnutrition in Sub-Saharan Africa: IMPAACT Protocol P1092
inferred← citeshttps://doi.org/10.1097/jto.0000000000000380openalex-snapshot
Efficacy of the Irreversible ErbB Family Blocker Afatinib in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI)–Pretreated Non–Small-Cell Lung Cancer Patients with Brain Metastases or Leptomeningeal Disease
inferred← citeshttps://doi.org/10.1097/rli.0000000000001043openalex-snapshot
Pharmacokinetics, Safety, and Tolerability of the Novel Tetrameric, High-Relaxivity, Macrocyclic Gadolinium-Based Contrast Agent Gadoquatrane in Healthy Adults
inferred← citeshttps://doi.org/10.1097/txd.0000000000000970openalex-snapshot
Sequential Cohort Analysis After Liver Transplantation Shows de Novo Extended Release Tacrolimus Is Safe, Efficacious, and Minimizes Renal Dysfunction
inferred← citeshttps://doi.org/10.1101/2021.02.04.429624openalex-snapshot
The epoxyeicosatrienoic pathway is intact in endothelial and smooth muscle cells exposed to aldosterone excess
inferred← citeshttps://doi.org/10.1111/all.16281openalex-snapshot
Aspirin hypersensitivity diagnostic index ( AHDI ): In vitro test for diagnosing of N‐ ERD based on urinary 15‐oxo‐ ETE and LTE 4 excretion
inferred← citeshttps://doi.org/10.1111/bcp.13591openalex-snapshot
A pharmacological rationale for improved everolimus dosing in oncology and transplant patients
inferred← citeshttps://doi.org/10.1111/bcp.14277openalex-snapshot
Application of a microdosed cocktail of 3 oral factor Xa inhibitors to study drug–drug interactions with different perpetrator drugs
inferred← citeshttps://doi.org/10.1111/bcp.15369openalex-snapshot
Phase 1 safety, tolerability, pharmacokinetics and pharmacodynamics results of a long‐acting C‐type natriuretic peptide prodrug, TransCon CNP
inferred← citeshttps://doi.org/10.1111/bcp.15380openalex-snapshot
Bedaquiline exposure in pregnancy and breastfeeding in women with rifampicin‐resistant tuberculosis
inferred← citeshttps://doi.org/10.1111/bcp.15433openalex-snapshot
Volumetric microsampling for simultaneous remote immunosuppressant and kidney function monitoring in outpatient kidney transplant recipients
inferred← citeshttps://doi.org/10.1111/ctr.14829openalex-snapshot
Tacrolimus 4‐hour monitoring in liver transplant patients is non‐inferior to trough monitoring: The randomized controlled FK04 trial
inferred← citeshttps://doi.org/10.1111/cts.12921openalex-snapshot
Pharmacoenhancement of Low Crizotinib Plasma Concentrations in Patients with Anaplastic Lymphoma Kinase‐Positive Non‐Small Cell Lung Cancer using the CYP3A Inhibitor Cobicistat
inferred← citeshttps://doi.org/10.1111/cts.13297openalex-snapshot
Dexamethasone exposure in normal‐weight and obese hospitalized COVID ‐19 patients: An observational exploratory trial
inferred← citeshttps://doi.org/10.1111/cts.13365openalex-snapshot
First‐in‐human, randomized, double‐blind, placebo‐controlled, dose escalation trial of the anti‐herpes simplex virus monoclonal antibody HDIT101 in healthy volunteers
inferred← citeshttps://doi.org/10.1111/cts.13884openalex-snapshot
Pharmacokinetics of Sofosbuvir/Velpatasvir and efficacy of an alternate‐day treatment in hemodialysis patients with chronic hepatitis C infection
inferred← citeshttps://doi.org/10.1111/jth.15439openalex-snapshot
First evaluation of the safety, pharmacokinetics, and pharmacodynamics of BAY 2433334, a small molecule targeting coagulation factor XIa
inferred← citeshttps://doi.org/10.1128/spectrum.02327-22openalex-snapshot
Antituberculosis Macozinone Extended-Release Tablets To Enhance Bioavailability: a Pilot Pharmacokinetic Study in Beagle Dogs
inferred← citeshttps://doi.org/10.1136/bmjopen-2018-023899openalex-snapshot
Plasma concentrations of second-line antituberculosis drugs in relation to minimum inhibitory concentrations in multidrug-resistant tuberculosis patients in China: a study protocol of a prospective observational cohort study
inferred← citeshttps://doi.org/10.1136/bmjopen-2019-033040openalex-snapshot
Study protocol for the assessment of nurses internal contamination by antineoplastic drugs in hospital centres: a cross-sectional multicentre descriptive study
inferred← citeshttps://doi.org/10.1136/bmjopen-2021-054788openalex-snapshot
Safety and pharmacokinetics-pharmacodynamics of a shorter tuberculosis treatment with high-dose pyrazinamide and rifampicin: a study protocol of a phase II clinical trial (HighShort-RP)
inferred← citeshttps://doi.org/10.1136/ejhpharm-2021-003036openalex-snapshot
Therapeutic drug monitoring of linezolid: HPLC-based assays for routine quantification of linezolid in human serum and cerebrospinal fluid
inferred← citeshttps://doi.org/10.1155/2015/576250openalex-snapshot
Development and Validation of Simple RP-HPLC Method for Intracellular Determination of Fluconazole Concentration and Its Application to the Study ofCandida albicansAzole Resistance
inferred← citeshttps://doi.org/10.1155/2015/796249openalex-snapshot
Sample Preparation and Extraction in Small Sample Volumes Suitable for Pediatric Clinical Studies: Challenges, Advances, and Experiences of a Bioanalytical HPLC-MS/MS Method Validation Using Enalapril and Enalaprilat
inferred← citeshttps://doi.org/10.1155/2019/9096409openalex-snapshot
Classic Prescription, Kai-Xin-San, Ameliorates Alzheimer’s Disease as an Effective Multitarget Treatment: From Neurotransmitter to Protein Signaling Pathway
inferred← citeshttps://doi.org/10.1155/2023/5119997openalex-snapshot
Simultaneous Determination of Three Compounds in Rat Plasma by UHPLC-QQQ-MS/MS and Its Application to Pharmacokinetics of Banxia Baizhu Tianma Tang
inferred← citeshttps://doi.org/10.1155/2023/9895595openalex-snapshot
Simultaneous Determination and Stability Analysis of Ten New Psychoactive Substances including Synthetic Cathinones, Phenethylamines, and Ketamine Substitutes in Urine Using Liquid Chromatography-Tandem Mass Spectrometry
inferred← citeshttps://doi.org/10.1155/ianc/9508534openalex-snapshot
An Ultrafast UPLC‐MS/MS Approach for Determining the In Vitro Metabolic Stability of Duvelisib in the HLMs: In Silico Screening for Metabolic Lability, ADME Features, and DEREK Alerts
inferred← citeshttps://doi.org/10.11606/d.75.2021.tde-11012022-110019openalex-snapshot
Crise de reprodutibilidade científica em química analítica: avaliação com foco na validação dos métodos e na incerteza dos resultados
inferred← citeshttps://doi.org/10.1177/00045632231159242openalex-snapshot
Validation and clinical evaluation of an ultra-performance liquid chromatography with ultraviolet detector method for plasma quantification of micafungin
inferred← citeshttps://doi.org/10.1177/1098612x231162836openalex-snapshot
Cat alpha-1-acid glycoprotein enzyme-linked immunosorbent assay: performance characteristics and reference intervals
inferred← citeshttps://doi.org/10.1182/bloodadvances.2024013275openalex-snapshot
Association of busulfan exposure and outcomes after HCT for patients with an inborn error of immunity
inferred← citeshttps://doi.org/10.1186/1475-2875-13-42openalex-snapshot
The development and validation of an LC-MS/MS method for the determination of a new anti-malarial compound (TK900D) in human whole blood and its application to pharmacokinetic studies in mice
inferred← citeshttps://doi.org/10.1186/1752-153x-7-7openalex-snapshot
Development and validation of ultra-performance liquid chromatographic method with tandem mass spectrometry for determination of lenalidomide in rabbit and human plasma
inferred← citeshttps://doi.org/10.1186/1752-153x-8-13openalex-snapshot
Simple, sensitive and rapid determination of linifanib (ABT-869), a novel tyrosine kinase inhibitor in rat plasma by UHPLC-MS/MS
inferred← citeshttps://doi.org/10.1186/s12906-018-2351-1openalex-snapshot
Pharmacokinetics and tissue distribution of monotropein and deacetyl asperulosidic acid after oral administration of extracts from Morinda officinalis root in rats
inferred← citeshttps://doi.org/10.1186/s12936-015-0618-2openalex-snapshot
Screening for an ivermectin slow-release formulation suitable for malaria vector control
inferred← citeshttps://doi.org/10.1186/s13054-019-2378-9openalex-snapshot
Optimization of the treatment with beta-lactam antibiotics in critically ill patients—guidelines from the French Society of Pharmacology and Therapeutics (Société Française de Pharmacologie et Thérapeutique—SFPT) and the French Society of Anaesthesia and Intensive Care Medicine (Société Française…
inferred← citeshttps://doi.org/10.1186/s13065-024-01172-9openalex-snapshot
Determination of indoxyl sulfate by spectrofluorimetric method in human plasma through extraction with deep eutectic solvent
inferred← citeshttps://doi.org/10.1186/s40360-020-00416-3openalex-snapshot
A randomized single-dose, two-period crossover bioequivalence study of two fixed-dose Paracetamol/Orphenadrine combination preparations in healthy volunteers under fasted condition
inferred← citeshttps://doi.org/10.1208/s12248-013-9542-yopenalex-snapshot
Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
inferred← citeshttps://doi.org/10.1208/s12248-013-9552-9openalex-snapshot
Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
inferred← citeshttps://doi.org/10.1208/s12248-014-9685-5openalex-snapshot
Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics
inferred← citeshttps://doi.org/10.1208/s12248-020-0419-6openalex-snapshot
Quantification of T Cell Binding Polyclonal Rabbit Anti-thymocyte Globulin in Human Plasma with Liquid Chromatography Tandem-Mass Spectrometry
inferred← citeshttps://doi.org/10.1208/s12249-020-01662-8openalex-snapshot
Physiologically Based Dissolution Testing in a Drug Development Process—a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions
inferred← citeshttps://doi.org/10.1212/wnl.0000000000001025openalex-snapshot
Dystrophin quantification
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