Toxicokinetics/ Dose Formulation
The toxicokinetic analyses indicated that the toxicokinetic profile (the Cmax and T1/2) of the test item had no significant difference. On the other hand, the dose formulation analysis indicated that the doses administered were as provided in the study plan.
Analysis and Discussions
The study was aimed at assessing the biological response of the rats to the test item (LAF 001). From the discussions above, it can be deduced that the study complies with the good laboratory practice principles as provided by the OECD and FDA. Besides, the organization of the study facilities, personnel, identification of the test systems, and the experimental design, dosage levels, collection of samples indicates compliance to the OECD-GLP guidelines (OECD 1998a; OECD 1998b). Moreover, the study was conducted in accordance with the OECD study plan for repeated dose oral toxicity testing in animals (rodents).
However, the study deviates from some of the principles of GLP involving the responsibilities of the sponsor such as provision of the certificate of analysis to support the claims made on the test item and its characterization. In addition, the study and the study facility in general demonstrated lack of a Quality Assurance programme and failure to incorporate a reference test item in the study.
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