We need an OEL/ADE for a proprietary compound that will never be listed in your catalog. Can Affygility Solutions prepare one?
Absolutely! Affygility Solutions can prepare a custom OEL/ADE monograph for your proprietary compound.
Since it is likely that we will need proprietary information such as internal preclinical studies and/or an investigator's brochure (IB); prior to receiving any data, we will need a non-disclosure agreement from your company.
The types of information (if available) that will be helpful in preparing your monograph will include:
- Genotoxicity assays such as an Ames test;
- Mechanism of action (if known);
- Therapeutic indication;
- Acute toxicity studies;
- Repeat dose studies, including species and any adverse effects;
- Anticipation human therapeutic dose;
- Target organs;
- Reproductive and carcinogenicity studies (if available); and
- Adverse health effects.
In most cases, turnaround times for these documents are 10-15 business days or less for each document. To obtain a price quote and additional information, please contact us to start the process.