Pathology

1.Describe tests that should be carried out to help evaluate the safety of a newly developed drug.
100 marks
The common measures that are used to evaluate the safety of a newly developed drug in laboratory settings are LD50 and therapeutic index.
Lethal Dose 50 or Median lethal dose is a test designed to determine the lethal status of various compounds. The LD50 value indicates the concentration of the drug that would kill half of a population that consumed it. It is used to determine the right amounts of prescription and avoid adverse effects of overdosing from newly developed drugs.
Fixed Dose Procedure (OECD 420; 1992). This test relies on observing toxicity at a minimum fixed dose level to test for the acute toxicity of a drug. From the observation, if the drug only less than 90% survive, it is classified as very toxic. For the minimum concentration of 5mg/kg, If more than 90% survive but there exist signs of toxicity, it is classified as toxic, and if more than 90% survive and no signs of toxicity, it is moved to a higher concentration using multiples of 10. This test is aimed at finding the right dosage of a newly developed drug and prevent toxic or harmful level consumption.
2. Give a critical account of the use of the Ames test in the detection of potential carcinogenic activity.
The Ames test is used to detect mutagens. Typically, the tests use Salmonella typhimurium. It detects reverse mutations in S. typhimurium by measuring the number of histidine-dependent (his-)…