Do generic drugs meet a bioequivalence standard?
Although people generally think of oral dosage forms, such as tablets, capsules, and liquids, when they think about generic prescription drugs, generic versions of other drug dosage forms, such as injections, patches, inhalers, and others, must also meet a bioequivalence standard.
What are bioequivalence measures?
Bioequivalence measures evaluated were drug peak plasma concentration (Cmax) and area under the plasma drug concentration versus time curve (AUC), representing drug rate and extent of absorption, respectively.
What does be stand for in pharmaceutical equivalence?
• Refresh the concepts of pharmaceutical equivalence bioequivalence (BE) for a generic drug product. Define a reference standard (RS) in abbreviated new drug application (ANDA) submission and Orange Book. Describe the general considerations in BE studies and Product-Specific Guidance (PSG).
How do you know if a drug is bioequivalent to the original?
Manufacturers must conduct studies to determine whether their version is bioequivalent to the original drug—that is, that the generic version releases its active ingredient (the drug) into the bloodstream at virtually the same speed and in virtually the same amounts as the original drug.
Récapitulatif d’électromagnétisme
Même qualité des génériques et des princeps
Les génériques et la bioéquivalence
Guideline for Bioequivalence Studies of Generic Products
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs
Annex 9
Bioequivalence of medicines
Bioequivalence for immediate-release solid oral dosage forms; Step 2
GUIDELINES FOR BIOAVAILABILITY & BIOEQUIVALENCE STUDIES
