Nedocromil Sodium
- CAS number
- 69049-74-7
- Application
- Nedocromil sodium is a medication considered as mast cell stabilizer which acts to prevent wheezing, shortness of breath, and other breathing problems caused by asthma.
- Molecular weight
- 415.3044 g/mol
- Molecular formula
- C19H15NO7.2Na
- Routes
- Nasal
SOCOSUR PDE monographs are a quick and efficient way to obtain:
- Risks identification
- Identification of potential critical effects
- Rationale for NOAEL values selection
- Complete description of adjustment factors F1 to F5 as well as PK correction
- Complete review of all relevant pharmaceutical and medical databases, public or private, European or not in accordance with EMA guideline EMA/CHMP/CVMP/SWP/169430/2012, signed by an European toxicological expert with full CV
Benefits of such PDE monograph
A 16 to 25 pages report optimized in case of Regulatory Body inspection with all calculation details and all bibliographic references linked to these calculations.
How to initiate a quotation request and a supplier qualification within your quality system?
