Bioequivalence and Bioavailability Forum

Dear Rupesh,

I think, there is no specific guideline for the stay of the subject after adverse event. But improtant thing is to make sure subject safetly. Clinically if physician judge that the subject is safe, can be checked out. This is completely and solely dependent on clinical evaluation of subject by physician. If the adverse event in not completely resolved, and checked out on medication, should be entered the same in checkout form.

Regards
Dhanusha

Dear Rupesh,

1. there is no specific guidance
   
   
2. Subject can be discharged early, or kept in ward longer, after an AE, depending on the AE, its severity and its resolution. We have kept a person for 2 days in ward after the discharge of rest of subjects since he was having high grade fever and we felt sending him home would be too risky for his health. During this time a doctor, custodian were available round the clock and appropriate meals were provided. Subject was paid extra for the extra stay.
   
3. In case vomiting occurs in 2-3 times Tmax period (IR drug), its advisable to withdraw the subject. In case the drug is ER, the withdrawal criteria can stretch for upto 24 hours depending on drug properties.

Regards

Dr. Gagandeep Singh
Senior Consultant
Domain Consulting Team - Lifesciences
Cognizant Technology Solutions

Dear Rupesh,
The subject should be kept in obesevation depending upon the T max of drug sa it cannot be justified that complete drug has come out with in a single episode of vomiting.

Dear rupesh,
I would like to say,

1. If subject has ADR then the severity of it, will decide about study continuation. The decision completely depend on Physician/Investigator.
   
   
2. Drug profile will be the second issue, IR or ER, in this case we more concern of vomiting. then i am completely agree with dr.gagandeep.infact we dont withdraw volunteer in ER study for 2-3 vomitings in first 4 hrs.and we get the good results also.
   
   
3. Now about stay, that you can do as per your SOP.just you have to pay some extra amount if you withdraw that volunteer from study and keep him for observation for day or 2.

regards
Dr.Tarak Parikh