Iron(III)-hydroxide polymaltose
- CAS number
- 53858-86-9
- Application
- Iron trivalent, oral preparations
- Molecular weight
- 449.1642 g/mol
- Molecular formula
- C12H22O11.Fe.3HO
- Routes
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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