| What is regulatory oversight of drugs? | ِAny drug to be marketed should be listed in regulatory authorities (FDA, MOPH...)
They should have quality-safety and efficacy. |
| How is the drug approval process? | It takes at least 10 years, and is very costly.
We have 2 stages, preclinical testing: In vitro to approve candidates (molecular testing) and then experimental testing on animal subjects in order to study reaction.
Then the second stage is the clinical testing, which is divided into 3-4 phases |
| What are the phases of clinical testing? | first 2 phases are done on healthy individuals in order to study toxicity of the substance, then we have phase 3 which is the premarketing phase, we compare the drug with gloden standard of the drug family.
And finally we have phase 4 which is post-marketing surveillence AKA Pharmacovigilence which is done throught the years to monitor drug safety |
| What happens after we are done with drug approval? | After the drug is approved, it gets patency, which is the exclusivity for the company to market a product, this lasts for however much the drug took time to get approved.
During this period no other company can compete with this product (However some make copycats) |
| What is the bioequivalence test? | Companies may make generic products of the original product, this generic is made of the same API but different excipients
To approve those generics no need for testing, only a bioequivalence test is done to see whether this generic has the same effects as the original or not. |
| How is the nomenclature of drugs? | Each drug has 3 names, chemical , generic (Easier to study than the chemical , put by the WHO) and proprietary/ trade name
Chemical and generic are put in lower case but trade name is in upper case |
