Genetic Toxicology

Genetic toxicology studies are conducted early in the safety testing program of pharmaceuticals and impurities for the detection of toxic, mutagenic, clastogenic and morphological transforming activity in medical devices, chemicals, food additives, etc. vivoPharm protocols are designed to according to international guidelines (OECD, FDA, EU etc) and in compliance with GLP regulations. vivoPharm provide clients with a reliable turn-around time and on time delivery of results. vivoPharm conducts its genetic toxicology studies in a tiered approach, starting with an AMES test, and progressing to the conduct of mammalian cell and in vivo assays, which are designed to assess the toxicological relevance of any earlier observations.

AMES

Regulatory Method

Bacterial reverse mutation test for identifying mutagenicity potential of test compound applying plate-incorporation and colony counting method.

  • 5 Strains of bacteria
  • Includes dose-range finding and main test (5 concentrations of test substance, with and without metabolic activation)

High Throughput Method:

High Throughput screening of mutagenicity potential of test compound applying liquid fluctuation and colorimetric technique.

  • 2 strains of bacteria, with and without metabolic activation (5 concentrations of test substance)
  • Reduced cost and compound requirements

Chromosome Aberration

In vitro genotoxicity test for identifying structural chromosomal aberrations as a potential of the test substance.

  • CHO-K1 cell line
  • Includes dose-range finding and main test (3 concentrations of test substance, with and without metabolic activation)

Rodent Micronucleus

In vivo genotoxicity test for detection of damage induced by test article to the chromosome.

  • Includes dose-range finding and main test with 3 dose levels of test substance
  • Includes dose-range finding and main test (3 concentrations of test substance, with and without metabolic activation).
  • Oral IP, SC, IM, IV dose routes available