Biorelevant.com Learning Centre

 BACKGROUND
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Biorelevant 101

How a medicine should be taken is usually explained in the patient information leaflet provided by the manufacturer. Whether a …

 BACKGROUND
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Drug Substance vs. Drug Product

Whether you're developing an NCE (new chemical entity) or the generic version of a marketed drug, it’s helpful to understand …

 BACKGROUND
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Taking Your Medicine

These are the 3 common ways a medicine can be taken: before a meal, with/after a meal or either before …

 BACKGROUND
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Gastrointestinal Fluids and Biorelevant Media

A drug encounters various types of gastrointestinal fluids as it journeys through the gut. These in vivo fluids have distinct …

 BIORELEVANT DISSOLUTION
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Disintegration and Dissolution

Disintegration is a physical process that occurs when a dosage form (e.g. tablet or gelatine capsule) breaks up into smaller …

 FED STATE
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What Is A High-Fat FDA meal?

A high-fat FDA meal is a standardized meal administered to patients or volunteers when conducting fed state/condition …

 BACKGROUND
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Bioequivalence

A bioequivalent drug product means the bioavailability and the clinical outcome of a Test Product and the Reference Listed Drug …

 BIORELEVANT DISSOLUTION
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Syringe Filter Compatibilty With Biorelevant Media

During a dissolution test, each sample that is taken must be passed through a syringe filter. This step ensures that …

 FED STATE
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Fed Gastric Dissolution Media: FeSSGF vs FEDGAS

Testing new or generic drug products in in vitro dissolution media that simulate in vivo gastric fluids after a meal …