1.1. Scientists at a drug company are working to develop a new pain relief drug.

Figure 1 shows the procedure that the scientists must work through before the new drug can be accepted and distributed to patients world wide.

Figure 1

(i) Outline what is involved in the preclinical tests of the drug.

(2)

(ii) Give the range for the number of volunteers needed to complete all the clinical trials for the new drug.

(1)

(iii) Describe how the clinical trials should be carried out.

(6)

1.2. Figure 2 shows the effect of penicillin on the structure of a bacterium.

Figure 2

Explain how the mechanism shown in Figure 2 helps to protect an individual from the harmful effects of the pathogen.