Summary of the Final Rule for the. Medicare Physician Fee Schedule for CY 2016. Table of Contents Page. Regulatory Impact Analysis 3. Determination of Practice Expense (PE) Relative Value Units (RVUs) 4. Determination of Malpractice Relative Value Units (RVUs) 5. Potentially Misvalued Services Under the Physician Fee Schedule 7.
Stability studies should include testing of those attributes of the API that. are susceptible to change during storage and are likely to inï¬ uence quality, safety and/or efï¬ cacy. The testing should cover, as appropriate, the physical, chemical, biological and microbiological attributes.
Based upon this data, long-term or. real-time stability testing conditions and accelerated stability. testing conditions have been derived. The standard climatic zones. for use in pharmaceutical product stability studies have been. presented in the Table 4.