Question

1)

IND’s are typically needed for the following: (more than one answer)

Group of answer choices

Human testing of a Monograph drug active in a new formulation using dose levels/concentrations approved in the Monograph.

Human testing of a Monograph drug active at a higher dose than that approved in the Monograph.

Human testing a Monograph drug active using a route of administration other than that approved in the Monograph

Human testing of a new chemical entity

2)

To grant a patent, the technology must be non-obvious and have utility. (True or False)

Group of answer choices

True

False

3)

Rectally administered suppositories can be used to avoid hepatic first-pass metabolism of systemically absorbed drug actives and this is their primary use in OTC drug products. (True or False)

Group of answer choices

True

False

4)

Which section(s) of the GI tract do NOT have villi present to increase absorptive surface area? (More than one answer)

Group of answer choices

Ileum

Descending colon

Esophagus

Jejunum

Cecum

5)

Under the FD&C Act, which of these shows that a lipstick is adulterated? (More than one answer)

Group of answer choices

Contains poisonous substances which might be injurious to user under the condition of use prescribed in the label

Contains a label that with listing of all ingredients

Contains a stand of stray hair inside the lipstick bullet

Contains small beads of liquid knowns as “sweating” around the lipstick bullet

Answer 1

1)ans: c) & d)

Because IND's mainly conduct study for a new entity or drug,to study an already spprappr drug for any new indication or administration.

But Drug dose levels are formulated as per ATC code.

2)True

Because patent requirements include that it should be new, useful and non obvious.

3)True

Because Rectal drug gives a proper systematic level for drugs ,though there is limited area of rectal mucosa.

4)ans: b&C ,descending colon and oesophagus

Because Villi is present only in small intestine.Ileum,jejanum and cecum are included in small intestine.so villi is only absent in oesophagus as it's tissue is stratified squamous without villi; Colon as its cells are less denser than this small intestine.

5)ans: a &c

According to FD & C adultratadul means any violation regarding cosmetic composition like containg any poisonous substance,decomposed substance,made under unclean conditions.