Answer:

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Explanation:

Joe M. Fowler BS, RQAP-GLP, ... James Greenhaw BS, LAT, in Nonclinical Study Contracting and Monitoring, 2013

Subpart A – General Provisions

This subpart OUTLINES various definitions and general responsibilities when conducting a GLP-compliant study.

Section 58.3 (Definitions)

This section defines various terms that are used throughout the GLPs. A few terms deserve special attention.

Good Laboratory Practices (GLPs)

Although GLPs were initially required for toxicological studies Christian (1995), this requirement was extended to all safety pharmacology studies in 1987 Sullivan (1995). The GLPs regulations are designed to ensure that safety-related studies are CONDUCTED under the direction of a study monitor and are audited by quality assurance personnel. In addition to toxicity and carcinogenicity tests, GLP also applies to pharmacodynamic studies designed to assess the potential for adverse effects Sullivan (1995). In general, most safety pharmacology studies are conducted under GLP conditions, with the majority of CONTRACT research ORGANIZATIONS being certified in this regard by regulatory authorities.