Before a new medicine or biologic can be marketed, its sponsor must show, through adequate and well-controlled clinical experiments, that it is effective.
It’s a clear directive from the regulators, and one that everyone in the industry respects and understands. But what if a crossover study, as we’ve discussed previously, isn’t the right fit for your drug?
Unlike a crossover study where at first one group receives treatment A and later followed by treatment B, a parallel study is a type of trial where two groups of treatments, A and B, are given so that one group receives A while another group receives B.
Also called „between subject“ and „non-crossover“ studies, parallel studies can be much more appropriate if any concerns about carryover effects are present. This type of study might also be more beneficial if the disease or disorder being studied has a likely chance of progression during the time in which the study takes place.
Commonly in this approach, participants are randomly assigned to treatment groups. Each treatment group may include a particular dose of the study drug, different drugs completely, or a placebo. Patients then remain in that same treatment group throughout the course of the study. The randomization of this is a major characteristic which ensures accuracy of the results and lower risk of being biased.
There are concerns about the use of parallel studies for some testing, specifically the concept of intra subject variability, which is defined as the variability in response to the drug occurring within the same subject, and for this reason alone its essential to choose a pharma testing provider who is highly experienced in not only conducting the tests, but advising and recommending the correct approach for your individual circumstances.
QUINTA-ANALYTICA is one such provider. Boasting a clinic which has the capacity of up to 60 beds means that bioequivalence studies in molecules with up to 25% intrasubject variability can be conducted at the same time, and with over 20 years experience in this field, you can guarantee that professionalism and knowledge come as standard.
Get in touch to learn more.
