Question

1. Jane has been working in a drug testing lab for a few years. She is very familiar with antimicrobial testing. She is given a new drug to test for susceptibility and sensitivity. Her report needs to be detailed, listing all of the organisms that are susceptible and resistant, to back-up her results for the Minimal Inhibitory Concentration.
   1. Working in a lab where funding is an issue, describe how you would test the new drug. Be very detailed.
   2. Working in a lab where funding is no concern, describe how you would test the new drug.
   3. Create a small sample chart of the data that you would need to include in the report.

Answer 1

a)Drug testing steps are comprehensive and long whether it is low funding lab or labs having  funds,

Some important points for low funding labs to reduce cost include, 1) Reduce the sample size to small clusters instead of testing drug in large population around the world 2) Before trial get proper approval and contract if any problem occurs for approval or contract it will cost high. 3)Check sponsorship or insurance availability it may be from pharmaceutical companies or any trust 4)Should have correct plan and protocol to reduce cost without compromising quality 5) Proper use of logistics and staffs , these are important points should be considered when testing a new drug in low funding lab.

Now we are going into steps of drug testing  

Drug testing includes 4steps mainly in which two steps are pre-clinical and next two steps are clinical . Three points also should be considered while testing a drug

1. Efficacy of drug- which means how will the drug work in the body , its pharmacokinetics metabolism elimination, action, how it will reduce pain or fever etc

2 . Toxicity - This include major side effects of drug , toxic effect on body

3. Dosage - what concentration the drug can be given to patient to get desired outcome . These are 3 main points for drug testing now the steps of drug testing

Step 1 -Given drug is tested in a lab on tissues and cells of humans that already kept in lab if its feasible then go to step 2- Drug is tested in animals in lab mainly small mammals like mice or rabbits watch for its effects if its working then go to next step  

Step 3 - this is clinical trial that is started testing in humans very minimal dosage of drug giving to healthy volunteers they are already kept ready for testing gradually dose increase if no problem, then test in diseased volunteers their dosage also gradually increase to get desired outcome. Then find out the optimal dosage . Here we should consider the efficacy , toxicity and dosage. Placebo test also done to minimize errors placebo test means giving one group volunteers the actual drug and other group a drug like non harmful substance . Without their knowledge this is done because if they know actual drug they received they will tell uncommon compliants which may affect trial. All these procedures are successful then drug is written up and peer reviewed means checked by other experts or scientists . Then comes stage 4 . Drug is market but it also reviewed in market by pharmaceutical companies experts and physicians and sent reports to regulatory authorities of that country. These are main 4 stages all these stages sent reports to regulatory authorities of country ( in US its FDA) they check it for more than 6months , they can interfere or stop it at any time.

b) All these above explained 4 steps are doing for testing a drug in sufficient funded lab.

c) Iam giving simple chart of drug testing  

Stage1> testing on human cells and many substances >stage2 testing on live animals if feasible go to clinical trial > stage3 testing on healthy volunteers at minimum dose gradually increases dose , test in disease affected persons find Optimal dose , placebo test, peer review > stage 4 drug in market reviewed frequently by experts sent reports to regulatory authorities for 6months or more then its approving in market.