This will be an excellent tool for many pharma and biotech companies. Excellent work Andrew Walsh in getting this completed!!
THE CPCI? ONLINE HBEL CALCULATOR IS NOW LIVE! CPCI?, in collaboration with Enriched Life Sciences & Technology, are very pleased to announce that the online HBEL calculator based on the guidance found in the ASTM E3219 “Standard Guide for Derivation of Health Based Exposure Limits (HBELs)” is NOW LIVE! ? If you are interested in using the HBEL Calculator, please go to our webpage and become a member of CPCI? (membership is FREE). ? https://lnkd.in/eTQwSGx7 ? Once you become a member of CPCI?, you will immediately have access to the CPCI? HBEL Calculator webpage, and can open the HBEL Calculator. After entering the necessary information, factors and justifications, the calculator can then quickly calculate an HBEL value for you. You can easily change the Point of Departure or the adjustment factors and recalculate the HBEL to see what the effect is. ? The HBEL Report Table that is shown in ASTM E3219 (Figure 4) can also be generated, but to do so, you will need to enter your full name and email address and the Report Table will be sent to you. The E3219 Report can then be conveniently inserted directly into the HBEL Monograph. This report will have your name as the “Qualified Expert” along with a date and time stamp. The benefit of the E3219 Report is that the calculation has been validated as correct and all required information per E3219 has been collected. This simplifies the QA review of the Monograph. This calculator is targeted specifically at, and is most appropriate for, OTCs/Generics/older drugs where the toxicological and clinical information necessary for the derivation of the HBEL are readily available from public sources. While the calculator can be used by innovator companies who have access to internal information, the target audience are primarily mid to small size companies and companies in the Rest of World (ROW) countries that are starting up their own pharmaceutical industries. These companies need HBELs, and cannot afford the high costs of HBELs, but have employees with sufficient education who could derive HBELs and would benefit the most from this tool. NOTE: the HBEL calculator has been “peer reviewed” and tested prior to this launch by a world-wide group of pharmaceutical toxicologists with positive feedback. Best regards, Andy