Bioequivalency Branding Clinical Trials 
Drug Patent Watch
DECEMBER 12, 2024
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.
Drug Patent Watch
DECEMBER 30, 2024
Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan. The ANDA must demonstrate bioequivalence to the Reference Listed Drug (RLD), which is the original brand-name drug approved for marketing in Japan.
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Druggist
MARCH 25, 2021
Cerelle and Cerazette are two brands of daily progestogen-only pill (POP), also known as mini-pill. In recent years prescribing of Cerazette in NHS decreased, in place of other brands, including Cerelle. Do generic, and branded drugs produce exactly the same effect? . Summary of the post: Cerelle vs Cerazette: are they the same?
XTalks
FEBRUARY 8, 2021
Biosimilars must show no clinically meaningful differences from their reference products in terms of both safety and effectiveness in order to be classified as highly similar. Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts.
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. Following QbD to guarantee a drug product's safety.
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