Toxicology Services:  Discovery and Safety Studies

AppTec offers a full-range of in vivo and in vitro preclinical safety evaluation programs. As the uniqueness of each product requires a case-by-case approach, we partner with clients to ensure all study components meet specific program objectives. 

Testing services are based on current FDA, ISO, ICH, OECD, KFDA, EMEA, JMHLW, JP, EPA, AAMI, HIMA, USP, ANSI, and ASTM guidelines and recommendations, and our quality systems have been audited and accepted by regulatory authorities worldwide.  AppTec scientists have extensive experience in designing preclinical safety testing programs, and we have provided services in support of many successful regulatory submissions in the U.S., Europe, and Asia.

TESTING SERVICES INCLUDE:

Acute Toxicity (in vivo)

       Range Finding

             - Up/Down

             - Limit Test

             - Maximum Tolerated Dose (MTD)

       Fixed Dose

Repeat Exposure (in vivo)

       Range Finding

       Subacute / Subchronic / Chronic

Genotoxicity (in vitro and in vivo)

       In vitro Bacterial Mutagenicity

       In vitro Mouse Lymphoma

       In vitro Chromosomal Aberrations

       In vivo Mouse Micronucleus

Tumorigenicity

Pharmacokinetic and Toxicokinetic Sampling

Local Tolerance (in vivo)

       Intravenous  

       Intraarterial   

       Intracutaneous

       Intramuscular

       Ocular Irritation

       Intraocular Irritation

       Mucosal Irritation

       Primary Skin Irritation

Immunotoxicity

       Delayed Hypersensitivity

       Immunogenicity - Anaphylaxis/Antibody Sampling

Biodistribution and In Vivo Gene Expression Studies

       Including molecular biology (nucleic acid extraction and qPCR)

STUDY COMPONENTS INCLUDE:

Animal Models

       Mice

       Rat

       Guinea Pig

       Rabbit

       Dog

       Pig

       Goat

       Sheep

Routes of Administration

       Dermal

       Intracardiac

       Intracranial

       Intradermal

       Intramuscular

       Intraocular

       Intraperitoneal

       Intravenous  

          [including continuous]

       Oral

       Subcutaneous

Clinical Pathology

      Chemistry

      Hematology

Histopathology / Immunochemistry

AppTec’s toxicology services feature:

       •  Model development 

       •  Study design development

       •  GLP-compliant studies

       •  Dedicated, isolated study suites

       •  Web-based access to study progress

       •  Interpretation of histopathology and other toxicology data 

Complete biocompatibility / safety testing, and custom implant studies also available.