- This article describes our testing of Ivermectin bioequivalence.
A significant issue with the FDA is that they do not appropriately test manufacturing facilities; in particular, their testing is far worse in foreign manufacturing facilities. This has created a dual pricing market, where the IVM from the higher quality countries is very expensive — even though the item is generic. Then inexpensive sources are of dubious bioequivalence. The case of IVM is why it is not as simple as a drug simply becoming a generic, and then the price becomes reasonable for a high-quality source.
The Problem With the FDA’s Lack of Testing and Bioequivalence Curves
The FDA does not test the outcomes of drugs in people but instead allows manufacturers to submit bioequivalence tests performed in labs. However, the standards for measuring bioequivalence are very low. The following quote is from the book Bottle of Lies.
Patients getting switched from one generic to another might be on the low end one day; the high end the next. The FDA allowed drug companies to use different additional ingredients, known as excipients, that could be of lower quality. Those differences could affect a drug’s bioavailability, the amount of drug potentially absorbed into the bloodstream. But there was another problem that really drew Graedon’s attention. Generic drug companies submitted the results of patients’ blood tests in the form of bioequivalence curves. The graphs consisted o a vertical axis called Cmax, which mapped the maximum concentration of drugs in the blood, and a horizontal axis called Tmax, the time-to maximum concentration. The resulting curve looked like an upside-down U. The FDA was using the highest point on that curve, peak drug concentration, to assess the rate of absorption into the blood. But peak drug concentration, the point at which the blood had absorbed the largest amount of drug, was a single number at one point in time. The FDA was using that point as a stand-in or “rate of absorption.” So long as the generic hit a similar peak o drug concentration in the blood as the brand name, it could be deemed bioequivalent, even the two curves reflecting the time to that peak looked totally different. Two different curves indicated two entirely different experiences in the body, Graedon realized. The measurement of time to maximum concentration, the horizontal axis, was crucial or time-release drugs, which had not been widely available when the DA first cre-ated its bioequivalence standard in 1992. That standard had not been significantly updated since then. “The time to Tmax can vary all over the place and they don’t give a damn.”
Our Approach to Testing
We have stepped in to address this issue by performing our independent testing but by doing actual animal testing. Technical lab tests are far less accurate than tests with real subjects. However, the problem is that many things that Ivermectin is helpful for are difficult and expensive to test. So we needed to find an outcome that was easy to observe and test. Luckily, this outcome is known and goes back to the origin of the drug.
Description of The Test
Over two months, we purchased and tested several products for their most easily observable and measurable item: effectiveness against parasites. As we cover in detail in articles for subscribers at this site, Ivermectin is effective against many things; however, parasites are the most measurable thing to test. As soon as the item is effective against parasites, its other benefits can be realized.
So far, we have tested eight well-priced brands thus far on rabbits and have selected our favorite manufactured brand. We are continuing this testing using other brands and working with a supplier that has agreed to provide the most up-to-date brands to their customers. Once we get these issues ironed out and the website they are custom-creating is up to our specifications, we will provide that source.
Why We Were Able to Test in a Reliable Fashion
The initial tests of Ivermectin were published, and we copied those tests. However, all of our tests were with well-priced generics.
Mites will often infect the interior of the large ears of rabbits — and rabbits, which is where we apply the mites, are easy to infect with mites, and it is straightforward to measure when the mites have been cleared from the rabbits. Mites are a common parasitic infection for rabbits in the wild. The testing is also humane as the mites are not very painful for the rabbits, mainly if the style is cleared quickly and the testing process can clear them. Rabbits in the wild that have mites will often result in skin damage to the ear as the mites burrow and reproduce. IVM works quickly as if the IVM is high quality; the mites are impacted rapidly by the IVM and will begin to die as their neurological system is affected by the IVM. Rabbits are treated with IVM, with a 200-400 mcg/kg dosage, SC, two or three treatments 10-21 days apart.
Where We Got the Testing Protocol
We followed this well-established protocol that we found reading the research into animal testing. IVM works the same way in humans as it does in animals. However, we tested human IVM on rabbits. Finally, if a less effective brand is not giving the desired outcome, all rabbits are given the most effective brand at the end of the test. We currently have 6 of these testing rabbits, and they are great pets and test subjects, are well cared for, and have an open area where they forage in a controlled setting.
Performing Effective Comparison Testing
And because of the measurability of mite infection, mite growth, and mite elimination in rabbits, we can test the effectiveness of IVM between different manufactured items. This test is also “real world” as it is tested in animals with measurable outcomes.
Covering Testing Costs
Subscribers receive our most up-to-date testing. After weeks of discussions with a supplier to carry the IVM that passed our tests, they have just brought their website for those we recommend to them online. Subscribe to the site, and you will have access to this source information.
Our Recommended Source of Supply
Our approved source for Ivermectin is Summit Products. This source makes Ivermectin much easier to obtain, and Summit Products developed that subsite only to sell the Ivermectin that passed our bioequivalence testing. (which you can read about here)