Your Preclinical to Clinical LC-MS Bioanalysis Division

Bioanalytical Services Nonregulated discovery bioanalysis

Our pharmaceutical and bioanalytical team consists of Principal Investigators and Scientists with an average of 15+ years of experience in non-regulated and regulated bioanalysis with a focus on method development to accelerate your compound’s validation.

You will also have full access to our Sample Management team to support the analysis of your studies in compliance with your in-life study, a Metrology team who can support in-house mass spectrometry maintenance, and a full Quality Assurance team with an impeccable 40+ year regulatory track record.

To talk to an expert about our Regulated Bioanalytical Services, please click here.

List of Assays

bioanalytical-services-bioanalysis-2-800

Pharmaceutical Capabilities

Sample Management and Sample Storage
Metrology and Instrument Qualification
Dose Formulation Analysis (DFA)
Stability Testing
In Vitro Bioequivalence Analysis
Bioavailability Analysis

Sample Analysis Types

Bioanalytical Support for Domestic and International Studies
Preclinical and Clinical Studies for Safety and Efficacy
Immunogenicity
Bioequivalence
Pharmacokinetics
- Phoenix^® WinNo
- Noncompartmental analysis

Speciality Compounds

Small Molecules by LC-MS/MS
- Proprietary and Nonproprietary Drugs
- Prodrugs
- Insecticides
- Synthetic analogues
- Inhibitors
- Metabolites
- Chemotherapeutics
- Anesthetics
- Antiandrogens
- Hormones
- Immunosuppressives
- Vaccines
Large Molecules or Biologics by LC-MS/MS
- Proteins
- Peptide(s)
- Oligonucleotides
- Nucleic acids

Sampling Techniques or Systems

Microdialysate
In Vitro:
- Hepatoc
- Media

Bioanalytical Methods List

Inotiv’s bioanalytical solution supports your program from preclinical research through clinical development. We are here to help you by delivering actionable insights with on-time results to move you to the next milestone. Our GLP nonproprietary methods have been validated in accordance with U.S. FDA Crystal City and current regulatory guidelines. You’ll benefit from our expert scientific team and state-of-the-art technologies to support your investigation into drug-drug interactions, concomitant drugs, and generics studies.

To talk to an expert about our nonproprietary methods, please click here.

Contemporary Platforms

Liquid Chromatography, Tandem Mass Spectrometry
- AB SCIEX™ Platform (4000, 5500, 6500, 7500)
Bio-Automation
- TomTec Quadra 96 Liquid Handling System
- Hamilton Microlab STAR Liquid Handling System
- TubeWriter™ 360
- SPEX SamplePrep 2010 Geno/Grinder Cell Lyser and Homogenizer
HPLC and UPLC systems:
Shimadzu Nexera^®
Agilent^®
Waters™
CTC and Shimadzu Multi-Plate Autosamplers
UV-Vis, fluorescence, electrochemical, charged aerosol detectors
SpectraMax^® M5 Microplate Readers (Vis, UV, Fl)