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SERVICES » Pharmaceutical Development » In-vitro
The ABC Difference

 

Pharmaceutical Development

Biotech Services-Recently Expanded!

DMPK and Bioanalytical Solutions (GLP)
Method Development & Validation
In-vitro DMPK Services
In-vivo DMPK Services
Bioanalytical Testing

Radiolabeling & Synthesis Solutions
non-GMP Services
CGMP Services
Phase 0 Development Support

CMC & QC Solutions (CGMP)
Method Development & Validation
Extractables/Leachables Studies
Trace Analysis & Structural Chemistry
Stability Programs and Release Testing

Drug Development Consulting

Environmental Assessments

Seamless Project Management
through Strategic Partnerships

DMPK in-vitro Services

ABC Laboratories provides GLP and non-GLP services for preclinical in-vitro and in-vivo programs. Our drug metabolism and pharmacokinetics experts reliably quantify and interpret results to put IND-enabling programs on the fast track. ABC's unique combination of radio-labeling expertise, in-vitro DMPK study design and execution, and a partnership with a leading cellular/subcellular service provider enables us to streamline preclinical programs, expediting the path to first-in-human studies.

Metabolic Stability

  • Interspecies Comparisons
  • Metabolism (S9, Microsomal, Hepatocytes)
  • Metabolite Profiling and Identification (Proposed Metabolic Pathway)

Cytochrome P450 Inhibition

  • IC50 and Ki Determinations
  • Mechanism-based Inhibition
  • Validated LC-MS/MS Methods

Cytochrome P450 Induction (ex-vivo and in-vitro)

  • LC-MS/MS Method for P450 Activity

Cytochrome P450 Reaction Phenotyping

  • Correlation Analysis
  • Chemical/Antibody Inhibition
  • cDNA Expressed Enzymes

Drug-Drug Interactions

  • In-vitro evaluation of drug-drug interactions
  • Analytical Method Development (HPLC or LC-MS/MS)

Protein Binding (in-vitro and in-vivo samples)

  • Equilibrium Dialysis
  • Ultrafiltration
  • Ultracentrifugation

Data Acquisition/Reporting

  • Analyst
  • Win NonLin
  • Sigmastat
  • Empower 2 
  • Daily backup of raw data
  • Detailed, customized reports & electronic reporting available
in-vitro DMPK

ABC Laboratories combines in-house metabolism expertise with industry-leading cellular and subcellular products and services to efficiently deliver complete in-vitro DMPK programs.