Bioequivalency Branding Generic Drugs 
Drug Patent Watch
OCTOBER 7, 2024
Pharmacokinetics (PK) plays a crucial role in the development and approval of generic drugs. PK studies help ensure that generic drugs are bioequivalent to their brand-name counterparts, meaning they have similar absorption, distribution, metabolism, and excretion (ADME) profiles.
Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.
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Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs. Regulatory System on Generic Drugs in Japan.
Drug Patent Watch
DECEMBER 11, 2024
Generic drugs play a crucial role in providing affordable healthcare options to millions of patients worldwide. One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). ” – Dr.
Pharmaceutical Technology
JULY 25, 2022
Unlike biosimilars, it is simpler for small molecule specialty generics to establish equivalence to their branded forms, explains Vasquez. Watanabe refers to the example of Teva’s immunomodulator drug Copaxone used for the treatment of multiple sclerosis, which the company produced and marketed as its own branded product.
Pharmaceutical Technology
OCTOBER 28, 2022
To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.
Pharmacy Checkers
FEBRUARY 14, 2020
Years ago, they took on the Food and Drug Administration in regards to Budeprion XL distributed by Teva Pharmaceuticals, the supposed generic equivalent to the popular antidepressant, Wellbutrin XL. Many readers complained that it just wasn’t cutting it compared to the brand name version. Just switch back to the brand!”
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