Generic Oral Controlled Release Product Development: Formulation and Process Considerations

This chapter contains sections titled: Introduction: Generic Drug Industry Dynamics Patents and Exclusivity Hurdles Faced by the Generic Industry Dosage form Design and Formulation Considerations Biopharmaceutical Considerations Regulatory Considerations for Generic CR Conclusions References

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Hauptverfasser: Ahmed, Salah U, Naini, Venkatesh
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description This chapter contains sections titled: Introduction: Generic Drug Industry Dynamics Patents and Exclusivity Hurdles Faced by the Generic Industry Dosage form Design and Formulation Considerations Biopharmaceutical Considerations Regulatory Considerations for Generic CR Conclusions References
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subjects CHEMISTRY
drug substance properties, critical role in bioequivalent generic CR product design
generic CR product probability ‐ bioequivalent to branded product and comparable in vitro drug release
generic oral controlled release product development ‐ formulation and process considerations
title Generic Oral Controlled Release Product Development: Formulation and Process Considerations
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