So that they be therapeutically equivalent demonstrable

1 Extensive & Appropriate Clinical Testing – The FDA should rethink its generic approval reports regarding generic AEDs, so that they be therapeutically equivalent demonstrable, not just bioequivalent to the innovator drug. ‘For the treatment of many neurological disorders and epilepsy in particular the FDA, the generic drug manufacturers prove their products are safe and effective, rather than placing the burden on doctors and patients, in order to prove that they are not safe,’said Liebler. Prudence & Patience – Before approving any more generic AEDs proposes Liebler that the FDA wait for a study which is currently supported by the National Institute for Neurological Disorders and Stroke planned that the problem of therapeutic equivalence against bioequivalence and the testing dangers when switching from a brand to a generic or subject to the random substitution of a generic for another . The trial is expected begin shortly, and when it is finished, it will allow the FDA to make the final data to its generic approval process applies to AEDs. ‘The FDA has confirmed that current studies measuring the therapeutic equivalence of many generic AEDs are not conclusive, these studies are to show that chemically chemically similar to the original brand, but does not prove that it is effective, it is risky for. FDA to approve generic drugs without complete data, so it makes sense to wait for conclusive available available. Given the pending NINDS research project, the good news is that long in coming long in coming, ‘said Liebler continuity. To ensure that patients with epilepsy need to work together to get the economic benefits of generics, pharmacies, insurance companies and healthcare providers, to create a system – like in Europe. Whilst ensuring that the patient receive the same generic drugs in the course of their treatment.

Epilepsy is a chronic neurological disorder that almost three million Americans. Each year about 200,000 people in the U.S. With with epilepsy. Though first occurrence can occur at any age, most often arises either epilepsy in early childhood or old age.

The outcome was assessed under three to 48 of the 70 items against GMC tests Invite. About the on the interim results for merely six of the 20 clinical and proficiencies.