Creating a new pharmaceutical product is a long and complex process. Outline the main stages of this process in the correct order.

There are various ways to administer drugs to a patient. One of the common methods, parenteral, is also known as injection. State and describe two other methods of administering drugs.

The efficiency of certain drugs is strongly dependent on the frequency and regularity of their administration. Explain the importance of patient compliance when the patient is treated with antibacterials.

drug design/discovery/screening/identifying lead compound;

preparation of analogues through combinatorial chemistry;

characterization of the new compound / in vitro testing / drug formulation/delivery/stability studies;

pre-clinical (toxicology and pharmacokinetics) tests / tests on animals/bacteria/cell cultures / LD₅₀ / OWTTE;

clinical tests/tests on humans;

ED50 to show improvements over existing drugs / OWTTE;

Penalize for incorrect order once only.

oral – by mouth / swallowing pills/powders / drinking liquids/mixtures / OWTTE;

inhalation – administering drugs into respiratory tract / inhaling gases/vapours/sprays/powders;

rectal – introducing drugs into the rectum/colon via the anus / using suppositories/enemas;

transdermal – diffusion through the skin/skin patches/ointments/therapeutic baths;

Accept other methods/variations with appropriate descriptions.

Award [1 max] if only two correct names or two correct descriptions are given.

irregular/interrupted treatment allows more bacteria to survive (and mutate) / failure to complete full course / OWTTE;

surviving bacteria develop/pass on resistance (to the drug);

Do not accept superbugs.

Part (a) was generally well answered although a lot of candidates seem to think that ED₅₀ is established on animals and a few, even more worryingly, linked LD₅₀ with human trials!

In part (b), descriptions were often missing but in (c) most understood the importance of frequency and regularity of drug administration.

In part (b), descriptions were often missing but in (c) most understood the importance of frequency and regularity of drug administration.