The long journey from molecule to medicine Flashcards
What is an excipient?
Excipients: substances other than the drug that
help deliver the medication to your system.
Excipients are chemically inactive substances
How many years does discovery and development take? +how many molecules?
3-4 years
- millions of molecules
What type of testing occurs in early discovery?
In vitro and in vivo testing
(cells in lab and animal cells)
How many years does preclinical take? + number of molecules
3-5 years
- 1-20 molecules
How many years + molecules does clinical testing take?
6-7 years
5-6 molecules
What type of testing takes place in preclinical?
human testing
How many years does review take and how many molecules?
0.5-2 years
1 approved molecule
What is a HIT compound?
molecule that shows the
desired type of activity in a screening
assay
What is an assay?
test systems that evaluate the
effects of the new drug candidate at the
cellular (in vitro), molecular, and
biochemical levels (ELISA)
What happens in phase 1 of pre clinical testing?
~100 healthy volunteers. Assess safety and pharmacokinetics (ADME)
effects on the body and side effects for safe dosage ranges. Probability of 66.4%
to enter Phase II
What happens in phase 2 of pre clinical testing?
100-500 patients with the disease. Assess drug safety and efficacy.
Patients may also receive a placebo or standard drug. Probability of 58.3% to
enter Phase III
What happens in phase 3 of pre clinical testing?
1000-5000 patients with the disease. Generate data about safety,
efficacy and the overall benefit-risk relationship of the medicine. Probability of
59% to be approved
What are the five potential reasons of failure of clinical trials?
- Toxicity
- Efficacy
- Pk properties or bioavailability
- Problems with patient recruitment, enrolment, and retention
- Lack of funding to complete a trial
