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Date May 2015 Marks available 1 Reference code 15M.3.sl.TZ2.14
Level SL Paper 3 Time zone TZ2
Command term Suggest Question number 14 Adapted from N/A

Question

Drug research and development is a lengthy and expensive process. Testing is required to determine the therapeutic window, tolerance and side-effects of a drug before it can be approved for use.

State the meaning of the term therapeutic window.

[1]
a.i.

Suggest why a narrow therapeutic window may be a problem.

[1]
a.ii.

State the meaning of the term side-effects.

[1]
b.

Markscheme

range of dosages/concentrations of drug (able to treat disease successfully) staying within safety limit / between effective/ED50 and toxic levels/LD50;

Do not accept definition of therapeutic index (ratio of LD50/TD50 to ED50).

Accept “lethal levels” for “toxic levels” even if laboratory animals are not referred to.

a.i.

toxic levels are easily reached / effective dose not given for fear of reaching toxic level / close medical supervision required;

Accept “lethal levels” for “toxic levels”.

a.ii.

adverse effects of drug / physiological/psychological effect other than that for which the drug was prescribed / secondary (undesired) effects of drug / OWTTE;

b.

Examiners report

Many candidates confused the definition of “therapeutic window” with “therapeutic index”. The nature of a narrow therapeutic window was also not well understood although the nature of side-effects was well articulated. The role of dimethicone as an anti-foaming agent was well understood overall. It was correctly identified as an anti-foaming agent where small bubbles are converted into larger ones and then released. This decreases "bloating" and increases rather than decreases "flatulence" which was seen quite often as a response in the use of dimethicone.

a.i.

Many candidates confused the definition of “therapeutic window” with “therapeutic index”. The nature of a narrow therapeutic window was also not well understood although the nature of side-effects was well articulated. The role of dimethicone as an anti-foaming agent was well understood overall. It was correctly identified as an anti-foaming agent where small bubbles are converted into larger ones and then released. This decreases "bloating" and increases rather than decreases "flatulence" which was seen quite often as a response in the use of dimethicone.

a.ii.

Many candidates confused the definition of “therapeutic window” with “therapeutic index”. The nature of a narrow therapeutic window was also not well understood although the nature of side-effects was well articulated. The role of dimethicone as an anti-foaming agent was well understood overall. It was correctly identified as an anti-foaming agent where small bubbles are converted into larger ones and then released. This decreases "bloating" and increases rather than decreases "flatulence" which was seen quite often as a response in the use of dimethicone.

b.

Syllabus sections

Options » D: Medicinal chemistry » D.1 Pharmaceutical products and drug action
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