Toxicity, teratogenic effects, and pharmokinetic properties of a drug compound are studied and recorded in an investigational new drug application (INDA).

Question

BlackTom AI · Accepted Answer

The statement under consideration pertains to where toxicity, teratogenic effects, and pharmacokinetic properties of a drug are studied and recorded.
Option 1: True. In the context of drug development, toxicity data, teratogenicity assessments, and pharmacokinetic (PK) properties are gathered during early and later phases and are documented in an Investigational New Drug (IND) application. This application is submitted to regulatory authorities to obtain approval for conducting clinical trials, and it includes preclinical toxicity studies, pharmacology, and PK/ADME data as part of the evidence package supporting safety and dosing in humans.
Option 2: False. If one were to claim False, the reasoning would need to demonstrate that these data are not part of an IND submission. In reality, regulatory guidance specifically requires inclusion of toxicity findings, safety pharmacology, reproductive toxicity/teratogenicity data, and PK information in the IND to justify human testing and to establish initial dosing and monitoring plans. The claim would be inconsistent with standard regulatory practice, where such information is essential for the IND review and approval process.

OC_DHYG370_202501SPI_BL-1 Week 1 Self-Check Quiz

Toxicity, teratogenic effects, and pharmokinetic properties of a drug compound are studied and recorded in an investigational new drug application (INDA).

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