SOP Guide for Pharma

BA-BE Studies: SOP for Administration of Study Drug in Fed State – V 2.0

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BA-BE Studies: SOP for Administration of Study Drug in Fed State – V 2.0

Standard Operating Procedure for Administration of Study Drug in Fed State in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/059/2025
Supersedes SOP/BA-BE/059/2022
Page No. Page 1 of 11
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To establish a standardized procedure for administering the investigational product (IP) under fed conditions to healthy volunteers in Bioavailability/Bioequivalence (BA/BE) studies as per protocol, regulatory, and GCP requirements.

2. Scope

This SOP applies to all fed studies conducted in the BA/BE clinical facility where the administration of the study drug is scheduled after a high-fat, high-calorie meal, as defined by regulatory guidelines and study protocols.

3. Responsibilities

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4. Accountability

The Principal Investigator is accountable for ensuring that dosing under fed conditions is compliant with the study protocol and regulatory standards.

5. Procedure

5.1 Standard Meal Composition

  1. Prepare a standardized high-fat, high-calorie breakfast containing approximately:
    • ~800-1000 kcal
    • ~50% fat, ~30% carbohydrate, ~20% protein
  2. Examples: Eggs, buttered toast, fried potatoes, milkshake.
  3. Document actual meal served in Annexure-1: Standard Fed Meal Record.

5.2 Meal Timing and Supervision

  1. Subjects must consume the entire meal within 30 minutes under supervision.
  2. Record start and end time of the meal in Annexure-2: Meal Intake Monitoring Log.
  3. Ensure no food or drink is consumed post-meal other than water (as per protocol).

5.3 Study Drug Administration

  1. Dose the subject exactly 30 minutes after completion of the fed meal, unless otherwise specified in the protocol.
  2. Verify subject identity and treatment allocation before dosing.
  3. Document exact dosing time, formulation, and initials of personnel in Annexure-3: Fed-State Dosing Record.
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5.4 Post-Dose Monitoring

  1. Observe subjects for any immediate adverse events post-dosing.
  2. Maintain subject fasting for the post-dose duration as defined in protocol (e.g., 4 hours).
  3. Document any protocol deviations or issues encountered.

5.5 Criteria for Exclusion

  1. If a subject does not complete the meal or vomits before dosing, consult the PI for continuation decision.
  2. Document such events in deviation log and Annexure-4: Fed-State Dosing Exclusion Log.

6. Abbreviations

7. Documents

  1. Standard Fed Meal Record – Annexure-1
  2. Meal Intake Monitoring Log – Annexure-2
  3. Fed-State Dosing Record – Annexure-3
  4. Fed-State Dosing Exclusion Log – Annexure-4

8. References

9. SOP Version

Version: 2.0

See also  BA-BE Studies: SOP for Subject Enrolment and Randomization Process - V 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Standard Fed Meal Record

Subject ID Meal Items Calories Fat % Meal Supervisor
VOL-059 Omelette, toast, butter, milkshake 950 52% Sunita Reddy

Annexure-2: Meal Intake Monitoring Log

Subject ID Meal Start Time Meal End Time Compliance Remarks
VOL-059 07:00 07:25 Yes Full meal consumed

Annexure-3: Fed-State Dosing Record

Subject ID Dosing Time IP Code Dosed By Remarks
VOL-059 07:55 TEST-A Dr. Arvind Shah No issues

Annexure-4: Fed-State Dosing Exclusion Log

Subject ID Reason for Exclusion Action Taken Investigator Date
VOL-059X Incomplete meal Excluded from dosing Dr. Arvind Shah 17/04/2025

Revision History:

Revision Date Revision No. Details Reason Approved By
14/01/2022 1.0 Initial Release Protocol implementation QA Head
17/04/2025 2.0 Fed-state specific annexures added Compliance with US FDA Fed Study Guidelines QA Head
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