How to Design a Pre-Clinical Study Trial
- It is the primary goal of this study to investigate the toxicity of a novel molecular entity (NME) in the test species by utilizing the clinical method of delivery and dose regimen designed for clinical use.
- A healthy animal population is used to test the safety or toxicity of various doses, which range from the lowest effective dose to the highest tolerable (or viable) dose.
- Under 21 CFR part 58, GLP, preclinical toxicity investigations must be carried out in accordance with regulations.
- Prior to implementation, an Institutional Animal Care and Use Committee must ensure that animal welfare standards are met (IACUC).
- There should be a valid certificate of analysis for each test item (COA).
- Dosing vehicles, compound preparation, and excipients employed in the test model species should all be well specified.
- Model species selection should be supported by data.
- All intended dosages, dose levels, methods of administration, and frequency and duration of administrations should be included in the experimental design.
- Detailed clinical observations, body weights, ocular observations, food consumption, and cutaneous observations must be defined before conducting animal studies.
- Clinical chemistry, hematology, coagulation tests, urinalysis, electrocardiograms, and any other relevant safety measurements with well-defined outcomes are included in this category.
- Pathology and histology are used to determine the extent of organ toxicity.
- On the first day of dosage, a single dose is collected for TK analysis, and on the last day of dosing, numerous doses are collected. If known metabolites of the NME show substantial in vivo exposures or therapeutic or toxicological actions, these should be investigated as well…
Why Glp is important in IND
For any investigational new drug development, it is essential to study clinical and non-clinical studies. Non-clinical studies are based on different steps like animal studies, and researchers follow good laboratory practices in these studies. In the GLP, they pass out from the following steps:
Determination of Drug Availability
A drug determination within the target cell helps to study the drug’s efficacy and gives better pharmacokinetics knowledge.
Absorption, Distribution, Metabolism, and Elimination (ADME)
Absorption includes the movement of the drug or absorption into the target body, distribution is the journey of a drug, metabolism refers to the working of the investigational new drug, and excretion or elimination is the removal of the drug from the body.
Every new drug discovery must meet the FDA requirements and require complete research. Without extensive animal testing, no drug is FDA approved. The informed consents are compulsory to submit for the investigational new drug. The investigational drug studies or programs provide complete data with repeated clinical trials for safety.
Pre-Formulation Studies
Pre-formulation studies are compulsory for the GLP, making the process secure and safe. The pre-formulation studies determine the physiological properties of the drug at the initial stages. It includes physicochemical characteristics of the compound before enabling IND. In animal model testing, scientists deal with the specie trial.
Investigational New Drug Approval
The investigational new drug takes 30 days, not many months, to get approval from the Food and Drug Administration (FDA). The new drug undergoes checks on the effect and other essential things in the 30 days. It doesn’t take many months.
Law and Regulations
The FDA aims to establish laws, regulations, and policies to protect human beings. They have to approve the investigational new drug by observing strictly. FDA makes sure that the drug mode of action is safe. It completed the trials under good laboratory practices and completed animal trials as well. FDA also reads every item’s manufacturing procedures, ingredients, and components before approving it.
IND Application
An investigational new drug development application is required or a request to the Food and Drug Administration (FDA) for the approval to administer the new drug to implement on the human or in the human population to cure the diseases.