Pharmacokinetics (PK)
Understanding the pharmacokinetic (PK) profile of a specific therapeutic is crucial for evaluating its effectiveness and safety. PK assessments play a vital role in determining the appropriate dosage, administration route, and schedule for preclinical and clinical trials. At 360biolabs, we offer comprehensive services, including bespoke PK assay development, validation, and sample testing to assist with all types of drug modalities and sample types.
Expertise With
Pharmacokinetic
(PK) assays:
Extensive Experience
We are experienced with handling and preparing a vast array of matrices, including serum, plasma, urine, saliva, CSF, vitreous humour, aqueous humour, milk, tissue lysates, and whole blood lysates.
Quality Compliance
We comply with GLP, GCP, and ISO/IEC 17025, as well as guidelines from regulatory bodies (FDA, EMEA, ICH) for method validation.
Reliable Results
We understand the importance of producing high-quality data with your PK assays. We constantly strive to design the best assays to provide robust and reliable results.
360biolabs Bioanalytical Solutions
Immunoassay / Ligand-binding Assays
Immunoassays support the assessment of a wide range of therapeutic and sample types across multiple indications such as cardiovascular, pulmonary, immunology, inflammation, metabolic, neurologic, oncology, genetic, autoimmune, and infectious diseases.
LC-MS/MS
360biolabs offers liquid chromatography-mass spectrometry (LC/MS) support for bioanalytical testing, conducting assays for large and small molecules using advanced instrumentation and software compliant with 21 CFR Part 11 for our regulated assay support.
Molecular Assays
Molecular assays such as qPCR and ddPCR are used in drug development, particularly for cell and gene therapies, to offer bioanalytical solutions.
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Central Lab Services
Our sophisticated central laboratory and logistics team ensure that “every sample counts” for all samples are received, logged, and stored.
Global Locations
The global team extends our service offering to the United States and Europe, expediting your early phase study into Phase 2 seamlessly.