Ensuring Global Safety with AUXO’s High-Quality Permitted Daily Exposure (PDE) Report
Auxochromofours Solutions Pvt Ltd
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Understanding PDE?
According to the EMA’s Guideline on setting health-based exposure limits for use inrisk identification in the manufacture of different medicinal products in shared facilities:
“The PDE represents a dose specific to a substance that is unlikely to cause adverse effects if an individual is exposed to it daily over their lifetime.”
The PDE is essential for conducting risk assessments in your facility as per ICH Q9 and is used in calculating the maximum allowable carryover (MACO).
Are PDE and ADE the Same?
Yes! Permitted Daily Exposure (PDE)?and Acceptable Daily Exposure (ADE) are essentially the same. Although the calculation variables provided by the European Medicines Agency (EMA) differ from those in the International Society of Pharmaceutical Engineers (ISPE) Risk-MaPP document, the outcome is the same.
What to Expect in AUXO?PDE Reports
Each PDE report from AUXO includes:
· Chemical and Physical Characteristics
· Therapeutic Indication
· Mechanism of Action
· Efficacy and Dose
· Safety Information
· Pharmacodynamics and Pharmacokinetics
· Toxicology Summary
· Carcinogenic, Reproductive, and Developmental Hazards
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· Selection of the Point of Departure (PoD)
· ADE (PDE) Calculations
· Choice of Adjustment and Modifying Factors
· Reference Citations
The Importance of Choosing the Right Partner
When acquiring PDE for APIs, selecting a partner with a quality-focused approach is crucial. At AUXO, our reports are carefully crafted by certified toxicologists, including DABTs and ERTs, ensuring you receive thorough and dependable PDE monographs
Partnering with AUXO ensures the highest quality and safety standards in your pharmaceutical processes. Let's collaborate to maintain global safety and compliance!
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PV,RA,MW Coordinator at thermofisher Scientific,ppd. M Pharmacy /Regulatory Affairs PG diploma Clinical Research
8 个月Looks great!