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Other Testing

Other Testing

Medical and Dental Device Testing

The company has expertise in safety evaluation tests for medical materials and devices. ADMET Group offers the following biological safety evaluation tests for medical materials and devices and other bio-implantable materials. The protocols for these studies are designed to meet the requirements of the International Organization of Standards (ISO 10993) and the Tripartite Biocompatibility Guidance document for testing medical devices.

ADMET GROUP has been testing dental materials and devices in accordance with the ISO 10993 standards and the American Standards Institute / American Dental Association Guidance document for testing dental materials and devices.

Pyrogen Testing in Rabbits
United States Pharmacopeia National Formulary, USP 24;NF 19, Pyrogen Test, pg. 1850, January 1, 2000.

Systemic Toxicity in Male and Female Mice
United States Environmental Protection Agency, Series 870 ñ Health Effects Testing Guidelines, Acute Oral Toxicity, OPPTS 870.1100, EPA 712-C-02-190. Adopted December 2002.

OECD Guideline for Testing of Chemicals, No. 401. Acute Oral Toxicity. Adopted December 20, 2002.

Intracutaneous Reactivity Test in Rabbits
United States Pharmacopeia National Formulary, USP 24; NF 19, In Vivo Biological Reactivity Tests, p. 1832, January 1, 2000.

Guinea Pig Sensitization Maximization Test (Magnusson-Kligman Method)
United States Environmental Protection Agency, Series 870 ñ Health Effects Testing Guidelines, Skin Sensitization, OPPTS 870.2600, EPA 712-C-03-197. Adopted March 2003.

OECD Guideline for Testing of Chemicals, No. 406. Skin Sensitization. Adopted July 17, 1992.

International Organization for Standardization. Biological Evaluation of Medical Devices. Part 10: Tests for Irritation and Delayed-type Hypersensitivity. ISO 10993-10, September 9, 2002.

Cytotoxicity Tests
In Vitro Cytotoxicity Using Agar Overlay; United States Pharmacopeia National Formulary USP 24; NF 19.

Colony Suppression Tests Using BABL/3T3 Cells.

In Vitro Neutral Red Cytotoxicity

In Vitro Blood Hemolysis Test

Limulus Amocbocyte Lysate (LAL Test); United States Pharmacopeia National Formulary USP 24; NF 19.

Genetic Toxicology Tests: (OECD and ICH Guidelines) Ames Salmonella Typhimurium/EscherichiaCcoli Mutagenicity Assay

In Vitro Chromosome Aberration

In Vivo Micronucleus Assay

Mouse Lymphoma Tk +/- Locus Mutation Assay

CHO/HGPRT Locus Mutation Assay

Unscheduled DNA Synthesis (DNA Repair)

Mammalian Cell Transformation


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Research and Testing Projects for Government Agencies and Industries

The senior scientific staff at ADMET GROUP have served as Principal Investigators, Project Managers and Project Directors on a variety of research and testing programs for US government agencies (National Cancer Institute, National Institute of Environmental Health Sciences and National Toxicology Program) and industries. These include Research and Testing Projects conducted under 6-month, 5-year and 10-year contracts. Some of these projects are still on-going and will continue for another 7 years. The following provides some information on the type of projects conducted for government agencies and industry.

  • Development of in vitro assays for screening compounds for anti-estrogen activity using human breast cancer cells ñ Validation and Testing for Breast Cancer Task Force
  • Development of in vitro assays for screening compounds for anti-cancer activity using human drug resistant cell lines ñ Validation and Testing for NCI
  • In Vitro drug discovery studies based on drug absorption - Industry
  • In Vitro drug discovery studies based on metabolism of drugs using human and animal primary cells and microsomes - Industry
  • Ames Mutation Assays - Validation and testing for NIH
  • In Vivo Cytogenetic Assays - Validation and testing for NIH
  • In Vitro Cell Transformation Assay - Validation and testing for NIH
  • In Vitro Mouse Lymphoma Mutation Assay - Validation and testing for NIH
  • In Vitro Cytogenetic Assays - Validation and testing for NIH
  • In Vivo Micronucleus Assay - Validation and testing for NIH
  • Evaluation of Metabolic Stability of Test Article in Liver Microsomes or Hepatocytes from Man, Rat, and Dog
  • Species Comparison of Metabolite Profiles of Test Articles: Studies with Human, Rat, Mouse, Dog, and Monkey Hepatocytes / Liver Microsomes
  • Drug-Drug Interaction Study: Determination of Metabolite Profile of Test Article in Human Hepatocytes
  • Drug-Drug Interaction Study: Metabolic pathway identification of test article using cDNA - expressed P450 Isoforms / Liver Microsomes
  • Drug-Drug Interaction Study: Evaluation of P450 inhibition potential of test articles in cDNA - expressed P450 Isoforms / Liver Microsomes / Hepatocytes
  • Drug-Drug Interactions: Evaluation of P 450 Induction Potential of Test Article in Human Hepatocytes
  • In Vitro Toxicity Screening and Mechanistic Toxicity Studies
  • In Vitro Hepatocyte Toxicogenomics

In addition, the scientific staff collaborated with the Japanese regulatory agency in validating and testing compound in vitro cytogenetic assays using different cell lines.

Regulatory Consultation on cGMP / GLP / DIN / IND / DSHEA / ICH Requirements
We provide regulatory consultation to the pharmaceutical, biotechnology and nutraceutical industries. The consultation areas includes:
  • Good Manufacturing Practice (GMP & cGMP)
  • Good Laboratory Practice (GLP)
  • Drug Identification Notification (DIN)
  • Dietary Supplement Health & Education Act (DSHEA)
  • International Conference on Harmonization (ICH)
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