Can I read Therapeutic Equivalence Guidelines for OIPs on EtoBox?
Therapeutic Equivalence Guidelines for OIPs by Medjouti Amira is a document available to read on EtoBox.
What is Therapeutic Equivalence Guidelines for OIPs about?
The document outlines the updated guideline by the European Medicines Agency (EMA) for demonstrating therapeutic equivalence between orally inhaled products (OIP) used in treating asthma and chronic obstructive pulmonary disease (COPD). It emphasizes a stepwise approach for establishing equivalence through in vitro and pharmacokinetic studies, while de-emphasizing the use of pharmacodynamic or clinical endpoints. The guideline is set for public consultation from April 12, 2024, to October 30, 2024, and repl
- Author
- Medjouti Amira
- Language
- EN