Generic pharmaceutical drug development
A generic pharmaceutical drug is a drug that contains the same chemical composition as the drug which was protected by chemical patents. The generic drug product development’s main steps include characterization of the reference product, design of a bioequivalent product, and bioequivalent study. Read https://pharmdevgroup.com/generic-drug-development/
A generic pharmaceutical drug is a drug that contains the same chemical composition as the drug which was protected by chemical patents. The generic drug product development’s main steps include characterization of the reference product, design of a bioequivalent product, and bioequivalent study. Read https://pharmdevgroup.com/generic-drug-development/
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Pre formulation
Before the actual trial formulations, pre-formulation is done to gain
information about the drug substance.
Their activities include:
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Review of the selected product document
Gathering samples of the reference product
Evaluating the physical characteristics of the product.
Determining reference drug release characteristics
Characterization of the drug to determine the form of the drug
Based on these activities, decisions are made according to the
formulation type and process of development. The reference product
itself determines the dosage form and strength.
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