Standard Operating Procedure for Meal Composition and Timing for Fed Studies in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/061/2025
Supersedes	SOP/BA-BE/061/2022
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 the process for determining, preparing, and timing the standardized high-fat, high-calorie meals administered before drug dosing in fed state Bioavailability/Bioequivalence (BA/BE) studies, ensuring consistency across all subjects and study periods.

2. Scope

This SOP applies to all fed BA/BE studies conducted at the clinical research unit, including the dietitian, study coordinator, and clinical team involved in meal planning, preparation, and supervision of consumption.

3. Responsibilities

• Study Dietitian: Plans and prepares the meal as per regulatory calorie and fat requirements.
• Clinical Research Coordinator: Ensures adherence to meal timing and documents intake.
• Ward Staff: Supervises meal consumption and records compliance in logs.

4. Accountability

The Principal Investigator is accountable for ensuring that all subjects receive the standardized meal within the specified time frame prior to drug administration.

5. Procedure

5.1 Meal Composition Requirements

1. Design a standardized high-fat, high-calorie breakfast with:
   • Total Calories: 800–1000 kcal
   • Fat Content: At least 50% of total calories
   • Carbohydrates: Approximately 30%
   • Protein: Approximately 20%
2. Typical food items may include eggs, buttered toast, sausages, hash browns, and full-fat milk or milkshake.
3. Record the meal composition in Annexure-1: Fed Meal Nutritional Breakdown Sheet.

5.2 Meal Preparation

1. Ensure ingredients are weighed and recorded for consistency.
2. Prepare the meal freshly on the day of dosing.
3. Ensure temperature and hygiene controls are followed in the preparation area.

5.3 Meal Serving and Timing

1. Start serving the standardized meal exactly 30 minutes before the planned dosing schedule.
2. Each subject must complete the meal within 30 minutes of serving.
3. Supervise and document the time of meal start and end for each subject in Annexure-2: Meal Consumption Log.

5.4 Monitoring Compliance

1. Observe subjects during meal consumption to ensure complete intake.
2. Record any leftover food or refusal in Annexure-3: Meal Deviation Log.
3. Subjects who fail to consume the meal as required should be reported to the PI for further action.

5.5 Quality Control of Meals

1. Cross-check the nutritional value using validated nutritional software or manual calculation.
2. File a certificate of meal composition with the study documentation.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• PI: Principal Investigator
• CRC: Clinical Research Coordinator

7. Documents

1. Fed Meal Nutritional Breakdown Sheet – Annexure-1
2. Meal Consumption Log – Annexure-2
3. Meal Deviation Log – Annexure-3

8. References

• US FDA Guidance: Food-Effect Bioavailability and Fed Bioequivalence 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: Fed Meal Nutritional Breakdown Sheet

Meal Item	Quantity	Calories (kcal)	Fat (g)	Carbs (g)	Protein (g)
Omelette	2 eggs	180	15	2	12
Buttered Toast	2 slices	240	12	24	4
Milkshake	250 mL	350	18	30	8

Annexure-2: Meal Consumption Log

Subject ID	Meal Start Time	Meal End Time	Compliance	Remarks
VOL-061	07:00	07:28	Yes	Meal completed

Annexure-3: Meal Deviation Log

Subject ID	Issue	Reported To	Action Taken	Date
VOL-061X	Left 25% of food	Dr. Arvind Shah	Excluded from dosing	17/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial Release	New SOP Implementation	QA Head
17/04/2025	2.0	Added nutritional breakdown and deviation handling	Protocol alignment and audit compliance	QA Head