Add to ORKGReport of the findings from a panel of the Office of Technology Assessment (OTA) regarding drug bioequivalence therapies. According to the report, the purpose of the Drug Bioequivalence Study Panel "was to examine the relationships between the chemical and therapeutic equivalence of drug products and to assess the capability of current technology -- short of therapeutic trials in man -- to determine whether drug products with the same physical and chemical composition produce comparable therapeutic effects" (p. 5)
Drug development is an expensive process that is marked by a high-failure rate. For this reason earl...
In this MiniReview, the main modifications made during the revision of the current Note for Guidance...
In vivo bioavailability studies are performed for new drug to establish essential pharmacokinetic pa...
Various aspects of bioequivalence are investigated in this paper. Some aspects dealing with bioequiv...
Bioequivalence is defined as the absence of a significant difference in the rate and extent to which...
Two drug products are considered bioequivalent ‘if their bio-availabilities... are similar to such a...
Bioequivalence (BE) means the absence of a greater-than-allowable difference between the systemic bi...
Includes bibliographical references and index.Bioequivalence using clinical endpoint studies / Chris...
A generic drug product (test product) is bioequivalent to an innovator product (reference product) w...
Bioequivalence testing is considered as a surrogate for the clinical evaluation of the therapeutic e...
This lecture material is covered in one and one-half fifty-minute lecture periods. The primary objec...
Abstract Aim The aim of bioequivalence studies is to assess the equivalence of two pharmaceutical fo...
The use of multisource essential drugs widely contributes to the accessibility to health care for po...
In order to be registered, generic drugs with a narrow therapeutic range have to undergo bioequivale...
The article describes specific aspects of biosimilars research and development. The aim of the study...
Drug development is an expensive process that is marked by a high-failure rate. For this reason earl...
In this MiniReview, the main modifications made during the revision of the current Note for Guidance...
In vivo bioavailability studies are performed for new drug to establish essential pharmacokinetic pa...
Various aspects of bioequivalence are investigated in this paper. Some aspects dealing with bioequiv...
Bioequivalence is defined as the absence of a significant difference in the rate and extent to which...
Two drug products are considered bioequivalent ‘if their bio-availabilities... are similar to such a...
Bioequivalence (BE) means the absence of a greater-than-allowable difference between the systemic bi...
Includes bibliographical references and index.Bioequivalence using clinical endpoint studies / Chris...
A generic drug product (test product) is bioequivalent to an innovator product (reference product) w...
Bioequivalence testing is considered as a surrogate for the clinical evaluation of the therapeutic e...
This lecture material is covered in one and one-half fifty-minute lecture periods. The primary objec...
Abstract Aim The aim of bioequivalence studies is to assess the equivalence of two pharmaceutical fo...
The use of multisource essential drugs widely contributes to the accessibility to health care for po...
In order to be registered, generic drugs with a narrow therapeutic range have to undergo bioequivale...
The article describes specific aspects of biosimilars research and development. The aim of the study...
Drug development is an expensive process that is marked by a high-failure rate. For this reason earl...
In this MiniReview, the main modifications made during the revision of the current Note for Guidance...
In vivo bioavailability studies are performed for new drug to establish essential pharmacokinetic pa...