Azithromycin dihydrate
- CAS number
- 117772-70-0
- Application
- Azithromycin Dihydrate is an azalide antimicrobial agent active in vitro against various pathogens
- Molecular weight
- 785.02 g/mol
- Molecular formula
- C38H72N2O12•2H2O
- Routes
- Injectable, 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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