Ever wonder how your medicine makes it to the pharmacy? The Covid-19 pandemic has given us a glimpse into the world of drug development. It’s a fascinating process and has been perfected over time to ensure that the medicine we take every day to ease our pain and keep us functioning is safe.
This blog shares with you the 5 steps in the drug development process in the US. Hope you find it interesting.
Step 1: Discovery and Development
Drug discovery is how new medications are discovered. Historically, drugs were mostly found by identifying active ingredients from traditional medicines or purely by chance. Afterward, classical pharmacology was used to investigate chemical libraries including small molecules, natural products, or plant extracts, and find those with therapeutic effects. Since human DNA was sequenced, reverse pharmacology has found remedies to existing diseases through testing.
Disease processes, molecular compound tests, existing treatments with unanticipated effects, and new technologies spur drug discovery through the cycle below.
Today drug discovery involves screening hits, medicinal chemistry, and optimization of hits to reduce potential drug side effects (increasing affinity and selectivity). Efficacy or potency, metabolic stability (half-life), and oral bioavailability are also improved in this step of the drug development process.
Step 2: Pre-Clinical Research
Once a lead compound is found, drug development begins with preclinical research to determine the efficacy and safety of the drug. Researchers determine the following about the drug:
- Absorption, distribution, metabolization, and excretion information
- Potential benefits and mechanisms of action
- Best dosage, and administration route
- Side effects/adverse events
- Effects on gender, race, or ethnicity groups
- Interaction with other treatments
- Effectiveness compared to similar drugs
Preclinical trials test the new drug on non-human subjects for efficacy, toxicity, and pharmacokinetic (PK) information. These trials are conducted by scientists in vitro and in vivo with unrestricted dosages.
Proof of Principle (PoP) are studies that are successful in preclinical trials and early safety testing. Proof of Concept (PoC) terminology is used almost interchangeably with PoP in drug discovery and development projects. Successful PoP/PoC studies lead to program advancement to the Phase II studies of dosages.
Step 3: Clinical Development
Once pre-clinical research is complete, researchers move on to clinical drug development, including clinical trials and volunteer studies to fine-tune the drug for human use. This is where you come in! Without the volunteers, new therapies cannot be approved.
Step 4: FDA Review
Once the new drug has been formulated for its best efficacy and safety, and the results from clinical trials are available, it’s advanced forward for wholistic FDA review. At this time, the FDA reviews and approves, or does not approve, the drug application submitted by the drug development company.
Step 5: FDA Post-Market Safety Monitoring
Following drug approval and manufacturing, the FDA requires drug companies to monitor the safety of its drug using the FDA Adverse Event Reporting System (FAERS) database. FAERS helps FDA implement its post-marketing safety surveillance program. Through this program, manufacturers, health professionals, and consumers report problems with approved drugs.
Be Well Clinical Studies is on the forefront of drug development every day. We are actively involved in Step #3 and invite you to join in. Contact us to learn how you can get involved in groundbreaking research that will have an impact on our health for generations to come.
Join us on Friday, February 4 from 10:00 to 10:30 a.m. to continue this discussion. Click here to register now.
Mark Carlson, MD