Question

1. What three phases of clinical drug testing are required before a new drug application can be approved?

A. On which of the five schedules is each of these drugs listed: heroin, marijuana, cocaine, and methamphetamine?

B. What are the important difference between a Schedule I and Schedule II controlled substance?

Answer 1

Answer 1. Clinical drug testing is to collect all the information about the drug's safety and efficiency after its production. For this trails are done to check its effects and results before entering the market for sale. There are three main steps in drug trials are-

Phase I :- in which a few number (below 100) of volunteers are given the medicines. These people are healthy and are paid for this step. This phase takes months to accomplish. The evaluation of its absorption and metabolism inside the body and its excretion from the body, is made and roughly 65-70% of drugs are passed in this phase.

Phase II :- in which the number of people is increased, that is, randomised communities or groups are given the normal medicine along with a control group of patients which are given the experimental medicine. The mixed evaluation of all is done wiyhout knowing the type of medicine given to judge the efficacy of the experimental medicine. This phase takes longer time ranging from months to years. It's feed back is provided to FDA for further processing.

Phase III :- this phase involves a large population and time taken is also many years to get proper or thorough results of the drugs. The efficacy on this large scale population decides the future of that medicine. About 1/3rd of the drugs reach phase III and those medicines which complete this last phase are subjected to be marketed on large scale by the pharmaceutical company and FDA, after the approval.

Answer 2. The five schedules for drugs are assigned on the basis of its acceptability in medical use and on the basis of its abuse or its dependency potential.

. Heroin- is a Schedule I drug. It has not been used in medical fields but have high potential for abuse.

. Marijuana - it also belongs to same Schedule I. It also has no ise in medicine yet, but has high abuse potential.

. Cocaine - it belongs to Schedule II, because it has high abuse potential. It can lead to psychological or physical dependency, due to its potential. This drug is very dangerous to use.

. Methamphetamine - it also belongs to Schedule II drugs, because its dangerous effects after use due to its high potential.

Answer 3. The main important difference between Schedue I and Schedule II is that can they ba used in medicine die to their high risks. The Schedue II drugs are more likely to have medical use but they are very dangerous in their effects like, and Schedule I hhas no possibility of usage in medicines.