Importance of Drug Knowledge for the Manufacturers

An important part of drug studies, clinical research involves in testing new medicines, devices and surgical techniques on human volunteers. Bioavailability and Bioequivalence (BA BE) Studies in clinical research involve comparing the formulation of different drugs from different manufacturers or comparing the same drug prepared in different batches by the same manufacturer.

All drugs will have an active ingredient that does the main work of the medication. Bioavailability is a term that defines the extent to which this active ingredient is absorbed in the blood. The absorbed active ingredient should then be transported to the active site where it reacts to provide the right results. The level of absorption will determine the extent of the efficacy of the drug. BA or Bioavailability studies track and measure the amount of active ingredient absorbed in the blood. Based on these statistics for clinical research methodologies are then followed to determine the effects of the drug on the human

The bioavailability studies of two drugs of almost similar formulations are studied to compare the effect and absorbency of their active ingredients. If the absorbance and therapeutic effect of two different drugs are similar, then they are said to be bioequivalent. Such drugs can be used interchangeably. For two drugs to be bioequivalent, they should pass various criteria. Their basic formulations should be similar, and the rate of absorbance should also be close. The dosage levels of the two drugs should be same and they should take relatively the same amount of time to reach the target site.

So, what are the benefits of doing BA/BE studies? First, they help us understand and determine if the active ingredient has any beneficial effect on the body. Secondly, if a drug manufacturer comes up with a different version of a medication that has an active ingredient that has already undergone a BA/BE clinical research studies, then they can just market that drug with minimum testing. The statistics obtained from its bioequivalent will prove to be good enough for satisfying the regulations. All drug manufacturers should do the BA/BE studies of the drugs they produce before it is introduced in the market.

This study is meant only for generic drugs and not specialized medicines. This clinical research study doesn’t have many phases and also involves just a small number of healthy volunteers. Moreover, the research is concentrated only on the active site, which means the studies can be done quickly and easily.