What is therapeutic equivalence?
prescription drugs can be grouped into two main classes: brands and generics. In order to obtain government approval, in the United States and elsewhere, these second generic versions must meet the standard of therapeutic equivalence. This requires the manufacturer to prove that his medicine is bioequivalent, with the same active ingredients, efficiency and side effects.
Most countries oversee their own medical and pharmaceutical industries and ensure that doctors prescribe drugs that prove to be safe and effective. In the United States, this task is processed by food and drug administration (FDA). For 2010, the agency approved 21 new Presription drugs, slightly from previous years. Some are new, branded drugs; Others are generations with therapeutic equivalence that are often tried to make extraordinary, branded drugs more accessible to the average patient.
Therapeutic equivalence is determined by the fulfillment of certain criteria. This includes a determination of whether the new alternatively of the same active ingredients, efficiency and the excrementhe. Other important considerations are whether a generic is administered and whether the body reacts in the same way as the brand's product. These drugs have the same marking requirements, chemistry inspections and testing periods as branded drugs, but the determination of bioequival eliminates stricter requirements for branded name for animal and clinical research-alpon at least in the United States. To find out, government chemists compare a model brand with a general assessment of whether they both have the same chemical composition, absorption and blood concentration over time.
Some drugs have therapeutic equivalence with a handful of other approved drugs. However, the most common model is branded and general pairing. According to the FDA Center for Drug Evaluation and Research, pharmaceutical companies have 17 years of patent protection for their branded products, then the competitor can try the general knock-off. After the Company asks for FDA approval, it must be before PRFour separate reviews were handed over and selling the medicine. The manufacturer's equipment is checked, the product labeling is checked in terms of accuracy, the bioequival of the drug is determined and the chemical composition is examined to determine whether it is equivalent.
Because generations are often produced by competitive pharmaceutical companies, new wording is sometimes suspected of having different characteristics than branded drugs, despite government consent. Sometimes controversy is caused. For example, in the first six months of 2007, the FDA was informed of 85 patients who reported a reduction in the effect when they switched from a branded depressive Wellbutrin® to alternative bupropion, despite therapeutic equivalence. After further studies, however, the agency concluded that the repeats were obviously anomaly.