Drug products, formulation development stability studies, accelerated

This section, as previously discussed, frequently poses problems leading to delays in NDA approval. Particular attention should be paid to the development of adequate data from studies conducted with commercial formulations packaged in container/closure system(s) to be marketed. It is critical that adequately validated analytical methods be used as early as possible in the investigational phases of drug development—no later than the initiation of phase 3 studies. Common defects in stability studies submitted to the FDA reflect the lack of acceptable long-term or short-term accelerated stability data to support the approval of an expiration date for the product. Another common problem occurs when studies are conducted using only one container size, yet the sponsor is... 

---