For approval of small molecule generics, FDA requires that evidence of average bioequivalence in drug absorption in terms of pharmacokinetic (PK) parameters be provided through the conduct of bioequivalence studies. This may be done using the area under the blood and/or plasma concentration-time curve and peak concentration (Cmax) .
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- Revlimid (lenalidomide) generics launch across Europe
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- Consequences of generics being favoured by healthcare providers
- What is meant by a generic medication and generic equivalence?
- The cost of developing drugs and use of generics
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- Successful increase of biosimilar adoption in a large integrated health delivery network
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