Add to ORKGThe demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard for immediate-release solid oral dosage forms. In this paper, we discuss BE and the BCS, as well as the issues that are currently relevant to BE as a pharmaceutical product standard
In December 2017, U.S. Food and Drug Administration (FDA) issued the Guidance for Industry; Waiver o...
Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat...
Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapam...
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/109935/1/cptclpt2011109.pd
Bioequivalence (BE) means the absence of a greater-than-allowable difference between the systemic bi...
Pharmacological therapy is essential in many diseases treatment and it is important that the medicin...
Unusual growth in pharma industry has provoked regulatory agencies to establish regulations regardin...
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/41492/1/11095_2004_Article_375175.pd
Generic drugs cannot be marketed without regulatory and clinical demonstration of "bioequivalence." ...
Introduction: Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issu...
This article describes an overview of waivers of in vivo bioequivalence studies for additional stren...
The US Food and Drug Administration (FDA) has recently suggested that the bioequivalence (BE) for pr...
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing ...
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing ...
Bioequivalence (BE) studies are scientifi c methods that allow comparison of diff erent medicinal pr...
In December 2017, U.S. Food and Drug Administration (FDA) issued the Guidance for Industry; Waiver o...
Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat...
Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapam...
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/109935/1/cptclpt2011109.pd
Bioequivalence (BE) means the absence of a greater-than-allowable difference between the systemic bi...
Pharmacological therapy is essential in many diseases treatment and it is important that the medicin...
Unusual growth in pharma industry has provoked regulatory agencies to establish regulations regardin...
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/41492/1/11095_2004_Article_375175.pd
Generic drugs cannot be marketed without regulatory and clinical demonstration of "bioequivalence." ...
Introduction: Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issu...
This article describes an overview of waivers of in vivo bioequivalence studies for additional stren...
The US Food and Drug Administration (FDA) has recently suggested that the bioequivalence (BE) for pr...
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing ...
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing ...
Bioequivalence (BE) studies are scientifi c methods that allow comparison of diff erent medicinal pr...
In December 2017, U.S. Food and Drug Administration (FDA) issued the Guidance for Industry; Waiver o...
Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat...
Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapam...