The following are required for Pharmacology and Toxicology Data for a new IND EX
ID: 259428 • Letter: T
Question
The following are required for Pharmacology and Toxicology Data for a new IND EXCEPT:
A)
Acute toxicity data from studies conducted in 2 species
B)
Results sufficient to determine the starting dose for clinical studies
C)
Conduct pharmacokinetic and toxicity studies using the same schedule, duration, formulation, and route as proposed clinical trial
D)
Histopathology are not necessary for an IND
A)
Acute toxicity data from studies conducted in 2 species
B)
Results sufficient to determine the starting dose for clinical studies
C)
Conduct pharmacokinetic and toxicity studies using the same schedule, duration, formulation, and route as proposed clinical trial
D)
Histopathology are not necessary for an IND
Explanation / Answer
Answer. Conduct pharmacokinetic and toxicity studies using the same schedule, duration, formulation, and route as proposed clinical trial
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