Pharmaceutical equivalence & Bioequivalence study
Ensuring pharmaceutical equivalence, bioequivalence for generic drug approval.
In approving a generic drug, the FDA requires pharmaceutical equivalence to the reference drug (identical amounts of same active drug ingredient in the same dosage form and route of administration), bioequivalence to the reference drug, and adequate labeling and manufacturing.
Bioequivalence is generally used to establish similarity between a generic drug and reference drug and is defined as the absence of significant differences in the availability of the active ingredient at the site of drug action.
Pharmaceutical equivalence studies
Concresco team is having expertise in pharmaceutical equivalence studies for generic dosage forms. This includes comparative dissolution profile studies in multiple and dissolution media as per product requirement.
Comparative studies with reference product for critical test/ specifications like:
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Assay
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Impurity profile
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Dissolution Profile
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Excipients Q1Q2
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Physical Properties (pH, viscosity, particle size and more)
Bioequivalence studies
Concresco team is having expertise in bioequivalence studies for generic dosage forms, This includes:
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Bio relevant in vitro tests to understand in vivo behavior of products and development of IVIVC.
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Bio-study strategy comprising of suitable study design, sampling points, protocol and number of volunteers, BA/BE studies involving in vitro end points, PD end points, special population and patients.
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Bio waiver strategy based on BCS class approach
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Special approaches for highly variable drugs & drug products
Why Concresco ?
Innovative Product Development
Dosage Form Proficiency
Global Expertise
ExperiencedLeadership Team
