BIOPHAR - Biopharmaceutical Aspects of the Active Pharmaceutical Ingredients and Pharmaceutical Equivalence Save

THERAPEUTICALLY EQUIVALENCE (TE)

• they can be substituted with the expectation of producing the same clinical effect and safety profile as the prescribed product

PHARMACEUTICAL EQUIVALENCE

• refers to the equivalence in active ingredients, strength, dosage form, route of administration, and labeling between a generic drug product and its reference listed drug
• ensures that the generic drug contains the same active ingredient(s) and is formulated in a manner that provides comparable drug availability

BIOEQUIVALENCE

• focuses on the equivalence in the rate and extent of drug absorption from the generic drug product compared to the reference listed drug
• demonstrate that the generic drug product releases the active ingredient into the bloodstream at a similar rate and to a similar extent as the reference product

PHARMACETEUTICAL ALTERNATIVES

refer to drug products that contain the same therapeutic moiety or its precursor but differ in certain aspects, such as dosage form, amount of active pharmaceutical ingredient (API) or chemical structure

STABILITY-RELATED THERAPEUTIC NONEQUIVALENCE

• refers to situations where different drug products, even if they are bioequivalent, may exhibit different therapeutic outcomes due to differences in their stability

EXCIPIENTS AND IMPURITIES-RELATED THERAPEUTIC NONEQUIVALENCE

• can have a negative consequences on the safety and effectiveness of a drug product
• could become apparent during chronic use of the drug
• absence or inappropriate amounts of excipients can compromise the intended therapeutic effect

POLYMORPHIC FORM-RELATED THERAPEUTIC NONEQUIVALENCE

two products can still be considered pharmaceutically equivalent even if they contain difference polymorphs

PARTICLE SIZE-RELATED THERAPEUTIC NONEQUIVALENCE

• can contribute to therapeutic nonequivalence
• unintended variations can affect content uniformity
• can also impact poor soluble (impact bioavailability)

SCALE-UP AND POST-APPROVAL CHANGES (SUPAC)

• outline the level of changes that can be made without requiring additional studies
• manufacturers must provide evidence that the changes are within the allowed limits and do not compromise the safety, efficacy, or quality of the drug product