In the OEL and ADE equations, it appears that you didn’t use a weight factor of 50–70 kg.
| If you are using a NOEL, NOAEL, or LOEL as the POD, and that dose is expressed in units of mg/kg, then you must use a weight adjustment of 50–70 kg to convert from a mg/kg dose to a mg/day dose. However, if the POD used is the lowest daily therapeutic dose, the body weight has already been considered in the dosage, therefore the use of a body weight factor is not required. In addition, for some types of drugs (i.e. chemotherapeutic, skin ointments, inhalable therapeutics), the dosing schedules can be quite complication and it requires an expert toxicologist to convert these an equivalent daily dose. Here at Affygility Solutions, we use 50 kg as the average body weight because it is slightly more conservative. It should be noted that the ADE is based on the adult human body weight. If the next batch is a batch for administration to pediatric populations, then additional adjustment factors must be applied. |