Standard Operating Procedure for Integrating BA/BE Studies in Global Clinical Strategy
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/047/2025 |
| Supersedes | SOP/BA-BE/047/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for aligning Bioavailability/Bioequivalence (BA/BE) studies with global clinical development strategies, ensuring their timely inclusion in regulatory submissions, lifecycle planning, and multi-region product approvals.
2. Scope
This SOP applies to all BA/BE studies planned for integration with global clinical strategies, including those intended for the US FDA, EMA, CDSCO, PMDA, Health Canada, WHO PQ, and other regulatory markets. It includes coordination across cross-functional teams for formulation, regulatory, and commercial alignment.
3. Responsibilities
- Global Clinical Development Lead: Ensures BA/BE studies are mapped within the overall clinical development plan (CDP).
- Regulatory Affairs: Provides input on country-specific BA/BE requirements.
- Clinical Project Manager: Oversees timelines and protocol harmonization across submissions.
- Medical Affairs: Advises on bridging studies and global value propositions.
4. Accountability
The Head of Global Clinical Development is accountable for the integration and regulatory alignment of BA/BE studies within the overall strategy for each therapeutic program.
5. Procedure
5.1 Strategic Assessment
- Review Target Product Profile (TPP) and Clinical Development Plan (CDP) for inclusion points of BA/BE studies.
- Identify the following:
- Reference products for each regulatory jurisdiction
- Bridging needs across dosage forms and strengths
- Waiver opportunities (BCS-based, formulation similarity)
5.2 Global Regulatory Mapping
- Compile applicable guidelines from global agencies using Annexure-1: Regulatory Mapping Sheet.
- Document differences in study design requirements (e.g., fasting/fed, single vs multiple-dose).
5.3 Protocol Harmonization
- Align clinical endpoints and PK parameters across protocols where submission in multiple regions is planned.
- Use Annexure-2: Global BA/BE Protocol Comparison Matrix for side-by-side review.
5.4 Lifecycle Planning
- Map BA/BE studies across:
- ANDA/505(j) submissions (US)
- Generic applications (EU)
- Post-approval changes and line extensions
- Maintain timeline using Annexure-3: Global Study Integration Tracker.
5.5 Stakeholder Review
- Conduct global clinical strategy meetings to finalize BA/BE plans with Regulatory, Formulation, and Commercial teams.
- Document meeting outcomes and update CDP accordingly.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- TPP: Target Product Profile
- CDP: Clinical Development Plan
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
7. Documents
- Regulatory Mapping Sheet – Annexure-1
- Global BA/BE Protocol Comparison Matrix – Annexure-2
- Global Study Integration Tracker – Annexure-3
8. References
- ICH M4 – Common Technical Document
- US FDA Guidance for Industry – BA/BE Studies for ANDAs
- EMA Guideline on Investigation of Bioequivalence
- CDSCO Guidance on Conduct and Reporting of BE Studies
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Regulatory Mapping Sheet
| Agency | Study Type | Specific Requirement | Last Reviewed |
|---|---|---|---|
| FDA | Fasted/Fed | Both required for IR tablets | 10/04/2025 |
| EMA | Multiple Dose | Optional unless modified-release | 12/04/2025 |
Annexure-2: Global BA/BE Protocol Comparison Matrix
| Parameter | US FDA | EMA | CDSCO | WHO |
|---|---|---|---|---|
| Cmax Metrics | ln-transformed | ln-transformed | ln-transformed | ln-transformed |
| Washout Period | ≥ 5 t½ | ≥ 5 t½ | ≥ 5 t½ | ≥ 5 t½ |
Annexure-3: Global Study Integration Tracker
| Study Code | Region | Submission Type | Planned Date | Status |
|---|---|---|---|---|
| BE-046 | US | ANDA | 01/07/2025 | Drafting |
| BE-046 | EU | Generic Application | 15/08/2025 | Pending |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial SOP | To align BA/BE studies with global strategy | QA Head |
| 17/04/2025 | 2.0 | Added annexures for protocol harmonization | Global lifecycle planning | QA Head |