Tag: therapeutic equivalence
How to Switch Back from a Generic to a Brand Medication Safely
Switching from a generic to a brand medication requires medical justification, proper documentation, and insurance approval. Learn the 7-step safe protocol, common pitfalls, and how to get coverage when it's truly necessary.
Population Pharmacokinetics: Using Real-World Data to Prove Drug Equivalence
Population pharmacokinetics uses real-world patient data to prove drug equivalence across diverse populations, offering a powerful alternative to traditional bioequivalence studies-especially for complex cases like pediatric, elderly, or renal-impaired patients.
Managing Therapeutic Equivalents in Combination Products: Dose Differences and Real-World Risks
Managing therapeutic equivalence in combination drugs isn't just about matching labels. Dose differences, formulation changes, and NTI drugs create hidden risks. Learn how to avoid dangerous substitutions and protect patient safety.
How to Verify the FDA Orange Book for Generic Equivalence
Learn how to use the FDA Orange Book to verify if a generic drug is therapeutically equivalent to its brand-name counterpart. Understand TE codes, search steps, and common pitfalls.