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Generic Drug Product Development: Specialty Dos...
This volume explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence...
Generic Drug Product Development: Specialty Dos...
Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who...
Generic Drug Product Development: Bioequivalenc...
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart; generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be...
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