Pharma_88 ☆ India, 2025-01-22 14:02 (21 d 21:52 ago) Posting: # 24344 Views: 511 |
|
Dear All, For Bioequivalence study conducted on patients, do we need to provide financial compensation to patients for the participation i.e. Housing or blood loss for Pharmacokinetic evaluation? any guideline from DCGI/ICMR or any regulatory body? — Regards, Pharma_88 |
drgunasakaran1 ★★ ![]() 2025-01-23 01:52 (21 d 10:02 ago) @ Pharma_88 Posting: # 24345 Views: 414 |
|
❝ For Bioequivalence study conducted on patients, do we need to provide financial compensation to patients for the participation i.e. Housing or blood loss for Pharmacokinetic evaluation? any guideline from DCGI/ICMR or any regulatory body? It is essential to provide appropriate compensation to patients who participate in bioequivalence studies. The amount of compensation is typically subject to approval by the Ethics Committee, which assesses the proposed compensation to ensure that it is justified and ethical. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
NK ☆ India, 2025-01-24 05:39 (20 d 06:15 ago) @ Pharma_88 Posting: # 24346 Views: 331 |
|
Dear Pharma_88, ❝ For Bioequivalence study conducted on patients, do we need to provide financial compensation to patients for the participation i.e. Housing or blood loss for Pharmacokinetic evaluation? any guideline from DCGI/ICMR or any regulatory body? Please refer ICH- GCP (E6) R3, 1.2.8 of ANNEX I If the trial participants are compensated for their participation in the trial, the IRB/IEC should review both the amount and method of payment to participants to assure that neither presents problems of coercion or undue influence on the trial participants. Payments to a participant should be prorated and not wholly contingent on completion of the trial by the participant. Reasonable reimbursement of participants for travel and lodging is not typically coercive. Regards NK Edit: Guideline linked. [Helmut] |