Review questions and answers

Review questions

1.1 What is the one significant difference between antibodies from hydro-phobic small-molecule drugs?

A.      Antibodies are hydrophilic.

B.      Antibodies are large molecular weight compounds.

C.      Antibodies typically have slow off rates on receptors that they occupy.

D.      All of the above.

1.2 What is the sequence of activities in the new drug development?

A.      Preclinical development > clinical development > compound characterization > commercialization

B.      Compound characterization > preclinical development > clinical development > commercialization

C.      Clinical development > preclinical development > compound characterization > commercialization

1.3 All drugs intended for human administration must be manufactured and released by utilizing practices that conform to which of the fol-lowing? Check any two that apply.

A.      Good manufacturing practices

B.      Good clinical practices

C.      Good laboratory practices

D.      The International Council on Harmonisation

1.4 Please categorize the number of subjects tested in clinical trials in the increasing order of the different phases of clinical studies.

A.      Phase 1 > phase 2 > phase 3

B.      Phase 1 > phase 3 > phase 2

C.      Phase 2 > phase 1 > phase 3

D.      Phase 2 > phase 3 > phase 1

E.       Phase 3 > phase 2 > phase 1

F.       Phase 3 > phase 1 > phase 2

1.5 Typical toxicology studies must be carried out in how many different species of animals before first human administration of a new drug candidate?

A.      1

B.      2

C.      3

D.      4

E.       5

1.6 Which of the following is not an analytical method used to test the quality of a drug?

A.      Purity

B.      Potency

C.      Quantity

D.      Water content

Answer:

1.1 D.

1.2 B.

1.3 A, C.

1.4 E.

1.5 B.

1.6 C.