Issues in PE of the Drug Product Flashcards
How does the drug product delivery system impact pharmaceutical equivalence (PE)?
Transdermal and oral ER drug products may have different delivery systems but are considered PE if they meet therapeutic equivalence requirements.
How do size, shape, and physical attributes of generic tablets and capsules affect pharmaceutical equivalence (PE)?
Not strictly a PE issue, but differences can affect patient compliance, medication errors, and GI transit times.
How do excipients impact pharmaceutical equivalence (PE)?
Generic and brand drugs may have different excipients but are still PE if they meet therapeutic equivalence requirements.
What is required for sterile solutions to maintain pharmaceutical equivalence (PE)?
Ingredients must be the same both qualitatively and quantitatively (e.g., ophthalmic solutions).
What is overage, and how does it affect pharmaceutical equivalence (PE)?
Overage (extra API to maintain bioavailability) is generally not allowed unless justified. Transdermal products with reservoir systems may require overage.
How do liposomes and emulsions affect pharmaceutical equivalence (PE)?
PE is difficult to establish due to differences in drug concentration in lipid and aqueous phases.
How do inhalation products affect pharmaceutical equivalence (PE)?
Differences in device design (particle size, plume geometry) may affect clinical efficacy, but certain products may still be PE if they meet therapeutic equivalence requirements.
How does the manufacturing process impact pharmaceutical equivalence (PE)?
Changes in compaction can alter drug release (e.g., harder tablets disintegrate more slowly), affecting performance.
