Standard Guide for Preclinical in vivo Evaluation in Critical-Size Segmental Bone Defects

Importancia y uso:

4.1 This guide is aimed at providing a range of in vivo models to aid in preclinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone.

4.2 This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens.

4.3 The user is encouraged to use appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein.

4.4 It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58.

4.5 Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs, respectively.

4.6 Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.

Subcomité:

F04.44

Referida por:

F2529-13R21

Volúmen:

13.02

Número ICS:

11.100.10 (In vitro diagnostic test systems)

Palabras clave:

animal models; biomaterials; bone; bone regeneration; bone repair; defect generation; devices; implants; in vivo; mechanical testing; synthetic biomaterials; TEMPs (tissue-engineered medical products);