Bioequivalence and Bioavailability Forum

Hi ElMaestro,

❝ What if a volunteer eats a psychotropic drug and then bites a dog? Who can hold who legally responsible if the investigator considers this occurrence of aggression drug related? - What if the drug was T? What if it was R? Who must pay the vet's fee when the dog needs stitches?

You are raising very important points calling for thoughtful considerations! Reminds me of an e-mail con­ver­sation I had with one of our mutual friends.

• Dear respectful Sir!
  I started my two-stage study with reference A and a street-dog ate the remaining IMPs. In the meantime the innovator went bancrupt. Can I use another generic as a reference in the second part, and if yes, another – better – analytical method? Awaiting your highly esteemed reply.
  Yours faithfully,
  ██████████████, MD, PhD, PharmD, MBA.
  
  
• Dear ██████████████,
  you should have an SOP in place to take care of such situations; this is a true deficiency in your Quality System. First of all you need to find this street dog and have it sign a consent form after informing it of the possible side effects of the drug. You will need an impartial witness such as the dog’s owner. As per DCGI recent recom­men­dations you should take a video and audio recording of the consenting process. Make sure that the consent form is signed from before the dog ate the IP. In case of a female dog run a pregnancy test. You have to take measures to ensure that the same dog does not eat further IPs for the next 90 days, as per the exclusion period in your protocol. You also have to inform immediately the Ethics Committee, unless you had very thought­fully planned for this possibility in your protocol. As per Schedule Y, DCGI only needs to be informed in case the study is on a new drug or a modified release formulation. For the remainder of the study, just run it as test versus test as per common practice.
  
  
• Dear respectful Sir!
  I will follow your suggestions and will include them in my updated SOPs.
  ██████████████, MD, PhD, et cetera.