Bioequivalence and Bioavailability Forum • Single dose PK study on Patients

Single dose PK study on Patients [Design Issues]

posted by Ohlbe – France, 2024-05-15 11:39 (250 d 18:58 ago) – Posting: # 23997
Views: 2,900

Dear Pharma_88,

You are referring to a general FDA guidance, which gives general recommendations. Did they publish a product-specific guidance for your product ? It would overrule the general guidance.

The type of study to be performed depends on how the drug is normally used according to its labelling. For instance:

if the drug is to be taken continuously (e.g. a kinase inhibitor taken orally): you will indeed have to do a steady-state study;
if the drug is given only on Day 1 of each cycle: well, you're not going to give it every day till steady state, it would kill the patient. In such a case you would do a single-dose study. See e.g. the doxorubicin (liposomal) draft guidance.

—
Regards
Ohlbe

Complete thread:

Single dose PK study on Patients Pharma_88 2024-05-15 05:37 [Design Issues]
- Single dose PK study on PatientsOhlbe 2024-05-15 09:39
  - Single dose PK study on Patients Pharma_88 2024-05-17 10:06
    - No, sorry Ohlbe 2024-05-17 13:45
      - No, sorry Pharma_88 2024-05-20 06:50
        
        Deviating from a guidance Helmut 2024-05-20 07:57
        
        Deviating from a guidance Pharma_88 2024-05-21 08:32
        
        No, sorry Ohlbe 2024-05-21 12:41