Phases of the drugs and bio-products studies
Bioproducts are those made of living sources and comprise blood components, vaccines, monoclonal antibodies and reactive proteins. Molecules of the active components are bigger as compared to those of other type drugs. Most common route of administration of these drugs is intra-venous (IV).
At the end of the last century, biotechnologists predicted antibodies drugs and recombinant biological products development. Modern biotech companies focus on creating small molecules. To develop new drugs after the license expiration, the company must obtain special approval.
Clinical trials
Clinical trials include the following stages:
1. Pre-clinical studies.
The drug is administered to two types of animals because it can affect differently. In future, alternative methods of the drugs’ trials will be developed, however, currently preclinical studies ensure the highest drug safety.
2. Clinical studies.
Drugs for severe illness are tested in small groups of volunteers, while drugs for milder conditions are tested in thousands of volunteers.
During testing, two arms of volunteers are designed; one gets study medication, while another receives a placebo. Further, subjects’ condition is monitored. If the investigators are aware of the drug type assigned to the subjects, this being a single blind method. Double-blind approach is a gold standard; neither subjects nor investigators are aware of the study groups distribution of the subjects. The obtained results are recorded according to statistical criteria.
3. Regulatory assessment.
In case study is successfully over, FDA approval is the next milestone. Applications contain detailed information about the drug composition, clinical studies, lab testing results and methods of development.
Next, NDA or BLA assessment follows; special Committee is organized for the drug assessment discuss all the pros and cons. Finally, the decision is made based on the discussion.
4. Postmarketing studies
Along with the manufacturer, FDA develops instruction leaflet for the drug which includes drug description, indications and contraindications for use, possible side effects, brief clinical observations, inter-drug interactions and other relevant information.
After marketing, there often the cases when additional studies are performed and new data are introduced into the instruction leaflet. Phase IV studies are aimed at obtaining more precise information about the drug. Companies are obliged to inform FDA of these studies’ results.