If an individual is exposed at or below this dose every day for their entire life, PDE represents a drug-specific dose that is unlikely to cause an adverse reaction.PDE has also become as an integral part of the cleaning validation program due to the possible risks of carryover contamination of residual active substances so as to comply with various Regulatory or cGMP requirements. PDE is also referred as Acceptable Daily Exposure (ADE).
Systemic hazard assessment through coordinated, strategized literature search; identification of critical effects; establishment of NOEL (no observed effect level)/NOAEL (no-observed-adverse-effect level) for extreme risk effects; and application of adjustment factors, including bioavailability correction factors for route to route extrapolation are all complicated steps in the PDE calculation. The PDE/ADE values are helped in cleaning validation in manufacturing facilities to further determine the utmost acceptable carryover (MACO values).
We at Maven provide the working procedures with ease are:
Identification of critical effects.
Point of departures (POD’s).
NOAEL, NOEL and LOAEL for clinical/non-clinical studies.
Hazard alters indications/ summary.
Review of acute toxicity (LD50 calculation), skin/ eye irritation and sensitization potential.
Repeat dose toxicity.
Reproduction and developmental toxicity.
Genotoxicity.
Carcinogenicity.
Clinical evidence with sensitive and vulnerable population.
Use of threshold of toxicological concern (TTC) approach for genotoxic substance.
Derivation of PDE values for uncommon or other routes of administration.
PDE values for solvents and impurities.
Technical and protocol support during cleaning validation.
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