Which of the following statements are true? a. Toxic effects of many biologics are due to...
Which of the following statements are true?
| a. |
Toxic effects of many biologics are due to exaggerated pharmacology |
|
| b. |
Preclinical toxicology studies in two species are always required for all biologics |
|
| c. |
Dosing and duration of dosing for initial clinical trials are supported by preclinical toxicology data. |
|
| d. |
One goal of an early Preclinical toxicology program is to determine the target organ(s) of toxicity |
Homework Answers
Answer:
Option a. Toxic effects of many biologics are due to exaggerated pharmacology.
Option c. Dosing and duration of dosing for initial clinical trials are supported by preclinical toxicology data.
Option d. One goal of an early Preclinical toxicology program is to determine the target organ(s) of toxicity.
Explanation
The main goals of conducting a preclinical trial are:
(1) Identification of an initial safe dosage and the schedule for Phase I clinical trials (First In Man) scheme in humans.
(2) Identification of the potential target organs for toxicity and to determine whether such kinds of toxicity can be reversed or not; and
(3) Identification of the safety parameters which are to be undertaken for clinical monitoring.
Thus, option a, c and d are true whereas option b is false and incorrect.
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