Bioequivalent or “Bioequivalence” means, a biological product that (i) is highly similar to the Product notwithstanding minor differences in clinically inactive components; and (ii) has no clinically meaningful differences between the biological product and the Product in terms of the safety, purity, and potency.
Bioequivalent means, with respect to the drug substance (or active pharmaceutical ingredient) contained in one pharmaceutical product in reference to the drug substance (or active pharmaceutical ingredient) of another pharmaceutical product, that the two substances are recognized by a Regulatory Authority as being both pharmaceutically and therapeutically equivalent to each other.
Bioequivalent means a chemical equivalent which, when administered to the same individual in the same dosage regimen, will result in comparable bioavailability.
Examples of Bioequivalent in a sentence
Bioequivalent pharmacokinetics for generic and originator hepatitis C direct-acting antivirals.
Hydrocortisone Granules Are Bioequivalent When Sprinkled Onto Food or Given Directly on the Tongue.
Bio-equivalent study charges paid to Raptim Research Ltd.` 3.93 lakhs (Previous year ` 60.63 lakhs).
Bioequivalent drugs may be converted from IV to PO as per approved criteria and protocol from Pharmacy and Therapeutics Committee and Medical Executive Committee.Pediatric medication orders will be weight-based.
Bioequivalent generics are chemically identical, making them largely fungible with one another.
More Definitions of Bioequivalent
Bioequivalent means a chemical equivalent which, when administered to the same individual
Bioequivalent means, inside the United States, "therapeutically equivalent" as evaluated by the FDA, applying the definition of "therapeutically equivalent" set forth in the preface to the then-current edition of the FDA publication "Approved Drug Products With Therapeutic Equivalence Evaluations" and, outside the United States, such equivalent determination by the applicable Regulatory Authorities as is necessary to permit pharmacists or other individuals authorized to dispense pharmaceuticals under Applicable Law to substitute one product for another product in the absence of specific instruction from a physician or other authorized prescriber under Applicable Law.
Bioequivalent means, with respect to an API in reference to another API, that: (a) the two APIs are pharmaceutically or pharmacologically equivalent to each other through the same predominant or primary mechanism of action and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same; or (b) the APIs are recognized by the Regulatory Authority for the relevant jurisdiction as being biologically equivalent or biosimilar in vivo such that the Regulatory Approval by such Regulatory Authority of one API is supported by the reference to the Regulatory Approval by such Regulatory Authority of the other API.
Bioequivalent or “BE” means a product that meets the FDA’s requirements for bioequivalence provided in 21 CFR 320.1 and Bioequivalence shall have a corresponding meaning.
Bioequivalent means, with respect one drug substance (or active pharmaceutical ingredient) contained in one pharmaceutical product in reference to the drug substance (or active pharmaceutical ingredient) of another pharmaceutical product, that: (a) the two substances are pharmaceutically or pharmacologically equivalent to each other through the same predominant or primary mechanism of action and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same; or (b) the two substances are or would be recognized by a Regulatory Authority as being biologically equivalent or biosimilar in vivo such that the Regulatory Approval of one such substance could be supported by the reference to the Regulatory Approval of the other. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Bioequivalent means equivalent antagonistic effect.
Bioequivalent or “Bioequivalence” has the meaning set forth in Section 9.5.5 (Competing Drugs).