What is the myth of Bioequivalence Studies?

Introduction:

Bioequivalence studies are safety assessments conducted by the FDA to ensure that generic drugs have the same composition as brand-name drugs. For example, if a brand-name drug contains 100 milligrams of the active ingredient, then its generic counterpart must also contain 100 milligrams of an active ingredient. However, bioequivalence studies have been misconstrued over time as being equivalent to efficacy studies; that is, they are not. There are many myths about bioequivalence studies and how they work in tandem with other factors like country of origin and manufacturing processes.

The myth that generic drugs have the same composition as brand-name drugs:

Generic drugs are not the same as brand-name drugs. Generic drugs must contain the active ingredient, which is the part of the drug that makes it work. This active ingredient needs to be in the same amount and form as that used by the brand-name product. If you were to compare two products containing identically shaped pills, you would find that they would weigh the same.

However, generic formulations may differ from their brand-name counterparts in some way(s) other than simply being "different" (e.g., color or taste). Inactive ingredients found in both types of products can include dyes used for coloring various components such as tablets or capsules; fillers such as microcrystalline cellulose; binders like gelatin; disintegrants like croscarmellose sodium (CCS); lubricants like magnesium stearate; coatings such as hydroxypropyl methylcellulose acetate succinate (HPMCAS), ethylcellulose and polyethylene glycols (PEGs); buffers like sodium citrate dihydrate (SCD) and calcium carbonate trihydrate (CCT); surfactants like polyoxyl 35 castor oil.

The myth that bioequivalence means “identical” or “equivalent”:

The myth that bioequivalence means “identical” or “equivalent”. This is a common misconception. The truth is, bioequivalence studies do not tell you the quality of your drug; they only determine whether it will be absorbed into your bloodstream at the same rate as its brand-name counterpart.

This is important because, if you take a generic medication and it does not get into your system as quickly as it should, you may feel like something isn't right with it—and this could cause side effects or complications down the road if left untreated.

The myth that bioequivalence studies are unnecessary

Myth: Bioequivalence studies are unnecessary.

Fact: Bioequivalence studies are necessary to show that a generic drug is equivalent to the brand name drug (and vice versa). If you're taking any medication, you must know that your body can absorb and process the medication as intended. That's why pharmacists have to watch out for allergies when they fill prescriptions with generic drugs—they need to make sure that the new version of your medicine won't cause any adverse reactions.

When it comes time to renew your prescription, you may decide that you'd rather not pay full price for an expensive brand-name drug when there are affordable generics available at pharmacies everywhere. If so, check out our list of top 10 generic medications on our website!

The myth that country of origin is a determinant factor in quality

While it’s true that the same drug may be manufactured in different countries, quality testing is conducted in each country on every batch of drugs manufactured. Each drug undergoes a thorough test before being approved by the government or sold on the market.

Drug approval testing is conducted by independent laboratories contracted by manufacturers and government authorities, who are then held accountable for their results.

The myth is that generics don’t work in the same way as brand-name drugs.

The myth that generics don’t work in the same way as brand-name drugs

To comprehend the misconception of bioequivalence, it is helpful to understand what a generic drug is. A generic drug is simply a version of an existing medication that contains the same active ingredient (a chemical compound used for its therapeutic properties) and identical inactive ingredients. A generic drug also has an equivalent dosage level and delivery mechanism as its brand-name counterpart.

To create a new version of an existing medication, the manufacturer must go through rigorous testing processes to prove that their product is therapeutically equivalent to the tried-and-true original on which it was based. This process can take up to three years from start to finish because it involves several different stages:

Development Stage — The manufacturer develops their formulation with similar characteristics as what they're trying to copy; this includes choosing which method will be used for production/manufacturing; determining whether or not there are any patents protecting competing versions so they can avoid legal problems down the line if necessary; conducting preclinical studies using animals where possible before moving onto human trials if needed (this helps ensure safety).

Bioequivalence studies don't fully determine if a drug is effective for a patient.

As mentioned above, bioequivalence studies only determine whether a drug is bioequivalent to another drug. The term “bioavailability” refers to the speed and extent that your body absorbs a medication and metabolizes it into its active form. For example, when you take an aspirin tablet that contains 325 milligrams of acetylsalicylic acid (ASA), your body breaks down ASA into salicylic acid (SA) through a series of chemical reactions. However, if you were to take two 325-mg tablets at once instead of one—a common mistake for patients who want faster pain relief—your body would still break down each dose separately until it reached 2 grams total in your system and then neutralize SA with either sodium bicarbonate or sodium citrate for the rest of those drugs' effects (e.g., headache relief) to kick in.

Conclusion:

Bioequivalence studies are an important part of the drug approval process. However, we need to be aware that these studies do not fully determine if a drug is effective for a patient. While there is some evidence that generic drugs may not work as well as brand-name drugs (particularly in cases where both formulations are available), it is important to remember that bioequivalence studies only test whether two or more formulations have the same amount of active ingredient per dose unit, not whether they have identical pharmacokinetic profiles or efficacy profiles.