Standard Operating Procedure for Administration of Study Drug in Fasted State in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/060/2025 |
| Supersedes | SOP/BA-BE/060/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define a standardized procedure for administering the study drug under fasting conditions in Bioavailability/Bioequivalence (BA/BE) studies, ensuring accurate pharmacokinetic assessment and regulatory compliance.
2. Scope
This SOP applies to all clinical trials involving fasted state dosing conducted at the BA/BE unit, covering activities related to fasting enforcement, subject compliance, dosing time, water restrictions, and documentation.
3. Responsibilities
- Clinical Research Coordinator (CRC): Coordinates subject instructions, ensures meal and fasting compliance, and oversees documentation.
- Ward Nurse: Monitors fasting period and prepares subjects for drug administration.
- Principal Investigator/Sub-Investigator: Verifies subject readiness and supervises drug administration.
4. Accountability
The Principal Investigator is accountable for ensuring all study participants meet fasting requirements prior to dosing and that the administration is conducted as per protocol.
5. Procedure
5.1 Fasting Confirmation
- Ensure a minimum 10-hour overnight fasting as per protocol (unless otherwise specified).
- Verify fasting start and end time in Annexure-1: Fasting Duration Compliance Log.
5.2 Pre-Dose Water Restriction
- Permit water intake up to 1 hour prior to dosing, as per protocol.
- Instruct subjects not to consume any food or caloric beverages post fasting start time.
5.3 Pre-Dose Checks
- Verify subject identity, treatment code, and fitness to receive dose.
- Reconfirm compliance with fasting conditions and document any deviation.
5.4 Drug Administration
- Administer the investigational product with specified quantity of water (e.g., 240 mL) within ±2 minutes of the scheduled time.
- Record exact dosing time, product code, and initials of personnel in Annexure-2: Fasted State Dosing Record.
5.5 Post-Dose Water and Food Restrictions
- Restrict additional water intake for 1 hour post dosing.
- Restrict food for at least 4 hours post dosing or as defined in the protocol.
- Monitor subjects for adverse events and document in relevant logs.
5.6 Handling Non-Compliance
- If fasting is not maintained, inform PI immediately for decision on subject withdrawal or continuation.
- Document deviation in Annexure-3: Dosing Deviation Record and protocol deviation log.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRC: Clinical Research Coordinator
- PI: Principal Investigator
7. Documents
- Fasting Duration Compliance Log – Annexure-1
- Fasted State Dosing Record – Annexure-2
- Dosing Deviation Record – Annexure-3
8. References
- US FDA Guidance for Industry: Food-Effect Bioavailability and Fed/Fasted Studies
- ICH E6(R2) – Good Clinical Practice
- Study-Specific Protocol
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Fasting Duration Compliance Log
| Subject ID | Fasting Start | Dosing Time | Total Fasting (hrs) | Compliance |
|---|---|---|---|---|
| VOL-060 | 21:00 | 07:00 | 10 | Yes |
Annexure-2: Fasted State Dosing Record
| Subject ID | IP Code | Dosing Time | Water Volume (mL) | Dosed By |
|---|---|---|---|---|
| VOL-060 | TEST-B | 07:00 | 240 | Dr. Arvind Shah |
Annexure-3: Dosing Deviation Record
| Subject ID | Deviation | Action Taken | Investigator | Date |
|---|---|---|---|---|
| VOL-060X | Consumed food at midnight | Excluded from dosing | Dr. Arvind Shah | 17/04/2025 |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial version | Protocol compliance | QA Head |
| 17/04/2025 | 2.0 | Expanded sections and annexures added | Operational clarity | QA Head |