Phenytoin sodium
- CAS number
- 630-93-3
- Application
- Phenytoin is classified as a hydantoin derivative and despite its narrow therapeutic index, it is one of the most commonly used anticonvulsants.
- Molecular weight
- 274.25 g/mol
- Molecular formula
- C15H11N2O2Na
- Routes
- Oral
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.
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