Bio pharma industry sees that the US FDA’s norms on Biopharmaceutics Classification System (BCS) based biowaivers will speed up drug development. A bio-waiver means that in vivo bioavailability (BA) and bioequivalence (BE) studies may be waived.
While BA studies is carried out to comprehend the relative amount of drug from an administered dosage which enters the systemic circulation and the rate at which the drug appears in the systemic circulation, BE assessed the expected in vivo BE of two proprietary preparations of a drug.
Two drug products containing the same drug substance or substances are considered bioequivalent if their bio-availabilities which is the rate and extent of drug absorption after administration in the same molar dose lie within acceptable predefined limits. These limits are set to ensure comparable in vivo performance, which is similarity in terms of safety and efficacy.
In vivo BE studies, the pivotal pharmacokinetic parameters area under the concentration time curve and maximum concentration are generally used to assess the rate and extent of drug absorption. The BCS-based bio-waiver approach is intended to reduce the need for in vivo bioequivalence studies. It can provide a substitute for in vivo bioequivalence. In vivo BE, studies may be exempted if an assumption of equivalence in in vivo performance can be justified by satisfactory in vitro data.
The BCS is a scientific approach based on the aqueous solubility and intestinal permeability characteristics of the drug substance. Two drug products containing the same drug substance are considered bio equivalent if their bio availabilities after administration in the same molar dose lie within acceptable predefined limits which are set to ensure comparable in vivo performance, i.e., similarity in terms of safety and efficacy.
The regulatory authority stated that BCS is a scientific approach based on the aqueous solubility and intestinal permeability characteristics of the drug substance. It categorizes drug substances into one of four BCS classes” Class I: high solubility, high permeability. Class II: low solubility, high permeability, Class III: high solubility, low permeability and Class IV: low solubility, low permeability.
A bio-waiver is applicable when the drug substances in test and reference products are identical. It may also be applicable if test and reference products contain different salts provided that both belong to BCS Class I which is high solubility and high permeability.
However a bio-waiver is not applicable when the test product contains a different ester, ether, isomer, mixture of isomers, complex or derivative of a drug substance from that of the reference product. Pro-drugs may be considered for a BCS-based bio-waiver when absorbed.
According to Prema Desai, pharma consultant, noted that BCS-based bio waiver approach is intended to reduce the need for in-vivo bio equivalence studies, drug products having a narrow therapeutic index are excluded from consideration for a BCS-based bio waiver.
Bio pharma industry sees that the US FDA’s norms on Biopharmaceutics Classification System (BCS) based biowaivers will speed up drug development. A bio-waiver means that in vivo bioavailability (BA) and bioequivalence (BE) studies may be waived.
While BA studies is carried out to comprehend the relative amount of drug from an administered dosage which enters the systemic circulation and the rate at which the drug appears in the systemic circulation, BE assessed the expected in vivo BE of two proprietary preparations of a drug.
Two drug products containing the same drug substance or substances are considered bioequivalent if their bio-availabilities which is the rate and extent of drug absorption after administration in the same molar dose lie within acceptable predefined limits. These limits are set to ensure comparable in vivo performance, which is similarity in terms of safety and efficacy.
In vivo BE studies, the pivotal pharmacokinetic parameters area under the concentration time curve and maximum concentration are generally used to assess the rate and extent of drug absorption. The BCS-based bio-waiver approach is intended to reduce the need for in vivo bioequivalence studies. It can provide a substitute for in vivo bioequivalence. In vivo BE, studies may be exempted if an assumption of equivalence in in vivo performance can be justified by satisfactory in vitro data.
The BCS is a scientific approach based on the aqueous solubility and intestinal permeability characteristics of the drug substance. Two drug products containing the same drug substance are considered bio equivalent if their bio availabilities after administration in the same molar dose lie within acceptable predefined limits which are set to ensure comparable in vivo performance, i.e., similarity in terms of safety and efficacy.
The regulatory authority stated that BCS is a scientific approach based on the aqueous solubility and intestinal permeability characteristics of the drug substance. It categorizes drug substances into one of four BCS classes” Class I: high solubility, high permeability. Class II: low solubility, high permeability, Class III: high solubility, low permeability and Class IV: low solubility, low permeability.
A bio-waiver is applicable when the drug substances in test and reference products are identical. It may also be applicable if test and reference products contain different salts provided that both belong to BCS Class I which is high solubility and high permeability.
However a bio-waiver is not applicable when the test product contains a different ester, ether, isomer, mixture of isomers, complex or derivative of a drug substance from that of the reference product. Pro-drugs may be considered for a BCS-based bio-waiver when absorbed.
According to Prema Desai, pharma consultant, noted that BCS-based bio waiver approach is intended to reduce the need for in-vivo bio equivalence studies, drug products having a narrow therapeutic index are excluded from consideration for a BCS-based bio waiver.
