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Biosimilars: The Center of Attraction of Pharma Industry
Pharmaceutical Articles

Editorial: Biosimilars – The Center of Attraction of Pharma Industry

Biosimilars, also known as follow-on-biologics are “duplicate” and licensed versions of the biologics that have lost their patent and are produced by some other company. Biosimilars have no clinically meaningful differences from the original or reference product. Moreover, regulations for biosimilar play an important role in maintaining the viability and balance between the original and biosimilar product. Thus, for the food and drug administration (FDA) approval, a reference to the innovator product is extremely crucial so that they can actively… Keep Reading

Main validation parameters of bioanalytical methods
Pharmaceutical Articles

Bioanalytical Method Validation and its Current Updates

Bioanalytics is defined as the analysis of a desired analyte in any biological fluids such as blood, plasma, serum, saliva, cerebrospinal fluid etc. Bioanalytical methods are therefore methods used to analyse an analyte in biological matrices. These methods are employed during the later stages of the drug development process (clinical trials) where the quantitative information about the drug after it has been administered inside a human body, is collected. For long, bioanalytical methods have been playing a crucial role in analysing… Keep Reading

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