M. Pharmacy Quiz-49

What does IND stand for in drug development?

Investigational New Drug

Industrial New Drug

International Novel Drug

Internal New Discovery

The main objective of IND enabling studies is to:

Evaluate the pharmacokinetic properties of the final marketed drug

Assess safety and toxicity before human trials

Determine the price of the drug

Approve the drug for market distribution

Which of the following systems are evaluated in Tier 1 safety pharmacology studies?

Gastrointestinal, renal, hepatic

Cardiovascular, central nervous, and respiratory

Skeletal, muscular, reproductive

Immune, integumentary, endocrine

The HERG assay is primarily used to assess:

Liver toxicity

Cardiac safety and QT prolongation risk

Renal toxicity

Respiratory depression

Tier 2 safety pharmacology studies include investigations of:

CVS, CNS, and respiratory systems

Dermatological and immune systems only

Gastrointestinal, renal, and other organ systems

None of the above

M. Pharmacy Quiz-49

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