Bioequivalency In-Vivo Marketing 
Camargo
NOVEMBER 11, 2020
When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.
Camargo
DECEMBER 22, 2021
In addition, the size and complexity of a development program can vary significantly depending on product characteristics, market dynamics, and regulatory pathway. Clinical pharmacology may also involve comparative bioavailability analyses, which are generally required for drug formulation bridging studies, to demonstrate bioequivalence.
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Drug Patent Watch
JANUARY 14, 2025
Benefits of the Portfolio-Centric Approach Risk mitigation Increased profitability Broader market presence Therapeutic Area Dominance Some manufacturers are choosing to become the Gordon Ramsay of specific therapeutic areas. These allow manufacturers to skip certain in vivo studies, saving time and resources[3].
Drug Patent Watch
DECEMBER 11, 2024
These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product quality. They provide recommendations on the design of in vitro and in vivo studies.
Pharmaceutical Technology
FEBRUARY 23, 2023
The sooner challenging and unfixable compounds are identified and killed in development, the less R&D expenditure will be incurred, allowing you to focus on compounds that have the legs to make to it market. Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products.
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