Association of Schools and Programs of Public Health
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
Good Clinical Practice
Good Clinical Practice or GCP is an international quality standard that is provided by International Committee on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.
Good Laboratory Practice
Good Laboratory Practice or GLP is a quality system concerned with the organizational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
Good Manufacturing Practice
Good Manufacturing Practice (GMP) is system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Industry/University Cooperative Research Centers
The U.S. National Science Foundation
A Protocol is a document which states the background, rationale and objectives of the trial and describes its design, methodology and organization, including statistical considerations, and the conditions under which it is to be performed and managed. The protocol should be dated and signed by the investigator, the institution involved and the sponsor. It can also function as a contract.
Systems and quality control procedures will be established to ensure that the trial is performed and the data generated in compliance with good clinical practice (GCP) and good laboratory practice (GLP). GCP and GLP provide a general framework enabling the efficient implementation and performance of all the functions and activities for a particular bioequivalence study as described in this document.