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A Complete Guide To Glp Toxicology Studies (FDA)
2 Nov 2020

GLP (Good Laboratory Practices) forms an important part of guidelines issued by the FDA for drug approval and registration. The importance becomes evident with toxicology studies that must be performed before clinical or human trials progress. Guidelines in the shape of GLP toxicology studies FDA can come in handy.

The guidelines from the FDA are non-binding. This is done to accommodate requirements or enable justification for a case-to-case basis.

GLP Role in Drug Development

GLP ensures the robustness of the safety data submitted to the FDA during the New Drug Application (NDA). This was instituted was because several submitted applications were found to have issues like insufficient documentation, inadequate planning, and several others. By introducing GLP, FDA ensured that the reports submitted were reliable and reflected the experiments undertaken.

To ensure the proposed drug is suitable and safe for humans in a clinical study, the FDA looks at GLP glp toxicology studies fda that also include toxicokinetic (TK) data.

The Purpose of GLP Toxicology Studies

Toxicological data is important to understand and assess the safety of a drug. This data can be useful in formulating doses, concentration, and the safety of a drug.

It isn’t rare to use non-GLP processes during the early phases of drug development. This is often used to get DMPK profiles (Drug Metabolism and Pharmacokinetic) and TK profiles of a proposed drug. With progress, adherence to GLP practices becomes more important. TK study to understand the unwanted or toxic effects of a drug is necessary for patient safety.

The required in vivo toxicology data for preclinical trials generally involves animals. Any TK study at this point must follow GLP and maintain adequate records and data.

According to the FDA, the general principle is to start human clinical trials with low systemic exposure in a small number of subjects. The trial should be extended or expanded on the demonstration of required safety.

Another aspect to consider is high dose selection for general toxicity studies. This can include the maximum tolerated dose (MTD), though it is not necessary for most drugs. These doses are intended to be useful in predicting clinical safety

Pharmacology studies relating to the pharmacodynamic effects of a drug should be completed in the pre-clinical phase. The availability of data from in vivo and in vitro is important as it affects the TK profile. Toxicokinetic and pharmacokinetic studies should be complete as well. However, the drug can behave differently in humans as compared to animals.

These profiles are continuously monitored during human trial phases, even if the preclinical data is encouraging. The results observed in animals will not necessarily translate the same in humans. Even in humans, additional changes may be seen with covariates relating to biomarkers, gender, race, BMI, and other factors.

Repeated dose toxicology studies provide an insight into drug behavior. Though dependent on the scope of the trial, these may also include other factors like duration and therapeutic indication. These particular studies should have data from preclinical trials conducted on two mammalian species, with one being a non-rodent species. Ideally, the duration of human trials should be equal to or less than the studies on animals.

Other areas of study to check for toxicity include genotoxicity, carcinogenicity, reproduction toxicity, immunotoxicity, or others, as needed on a case-by-case basis.

GLP studies toxicology
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