Standard Operating Procedure for Planning of BA/BE Studies in Pharmaceutical Development
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/001/2025 |
| Supersedes | SOP/BA-BE/001/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a systematic and standardized approach for planning Bioavailability (BA) and Bioequivalence (BE) studies that ensures regulatory compliance, data integrity, and successful study execution aligned with global guidelines.
2. Scope
This SOP applies to all personnel involved in the design, initiation, and coordination of BA/BE studies including clinical, regulatory, and project management teams across the pharmaceutical development lifecycle.
3. Responsibilities
- Regulatory Affairs Team: Reviews country-specific guidelines and initiates regulatory planning.
- Clinical Research Manager: Leads planning activities, timelines, and resource allocations.
- Medical Writer: Prepares study synopsis and protocol drafts.
- Bioanalytical Lead: Assesses analytical feasibility and method validation needs.
- Project Manager: Coordinates planning milestones and stakeholder inputs.
4. Accountability
The Head of Clinical Research is accountable for ensuring that BA/BE study planning adheres to applicable regulatory guidelines and internal quality systems.
5. Procedure
5.1 Preliminary Feasibility Assessment
- Obtain product development briefing and determine BA/BE requirement based on regulatory strategy.
- Check for available product-specific guidance documents (e.g., USFDA PSG, EMA Guideline).
- Review reference product literature including SmPC, FDA Label, or equivalent.
- Confirm reference product availability in intended regulatory markets.
5.2 Stakeholder Meeting and Kickoff
- Organize a cross-functional kickoff meeting including representatives from Clinical, Regulatory, QA, Bioanalytical, and Formulation teams.
- Establish key planning deliverables and timelines.
- Document all meeting minutes and circulate with action items.
5.3 Drafting of Study Synopsis
- Develop study synopsis including objectives, study design (fasted/fed), proposed dosage, and analytical approach.
- Align synopsis with regulatory guidance and submit for internal review and approval.
- Include statistical methodology outline for endpoint analysis.
5.4 Study Design Considerations
- Select appropriate study design: crossover, parallel, replicate, or single-dose.
- Document justification for design choice in the synopsis.
- Plan washout period, sample size, and dosing conditions.
5.5 Resource and Site Planning
- Identify qualified CROs or clinical sites experienced in BA/BE studies.
- Initiate vendor qualification and feasibility check.
- Evaluate study conduct timeline with selected site.
5.6 Regulatory Pathway Evaluation
- Check if pre-submission meetings are required with CDSCO, USFDA, EMA, etc.
- Plan for necessary submissions such as Form 44 (India), IND/ANDA (US), or EudraCT registration (EU).
- Prepare draft Gantt chart with projected timelines for protocol finalization, ethics submission, and first subject dosing.
5.7 Risk and Contingency Planning
- Perform preliminary risk identification including volunteer recruitment, analytical turnaround, and product procurement delays.
- Develop mitigation plans and include in the risk register.
- Schedule periodic review meetings to track planning progress.
5.8 Documentation and Approval
- Compile planning package: study synopsis, regulatory roadmap, risk register, and kickoff meeting minutes.
- Route documents for internal QA and management approvals.
- Archive final documents in the Study Planning Section of eTMF.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- SOP: Standard Operating Procedure
- GCP: Good Clinical Practice
- CDSCO: Central Drugs Standard Control Organization
- PSG: Product Specific Guidance
- eTMF: Electronic Trial Master File
- SmPC: Summary of Product Characteristics
7. Documents
- Study Planning Checklist – Annexure-1
- Study Synopsis Template – Annexure-2
- Risk Assessment Log – Annexure-3
8. References
- ICH E6 (R2) – Good Clinical Practice
- WHO Guidelines on Bioequivalence Studies
- USFDA Guidance for Industry – Bioavailability and Bioequivalence Studies
- EMA Guideline on the Investigation of Bioequivalence
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Study Planning Checklist
| Item | Status | Responsible | Remarks |
|---|---|---|---|
| Kickoff Meeting Conducted | Completed | Rajesh Kumar | Held on 05/04/2025 |
| Site Feasibility Checked | Pending | Sunita Reddy | Expected by 18/04/2025 |
Annexure-2: Study Synopsis Template
| Study Title | Comparative BA/BE of Test and Reference |
|---|---|
| Study Type | Randomized, Single-Dose, Crossover |
| Number of Volunteers | 36 |
| Dosing Condition | Fasted |
Annexure-3: Risk Assessment Log
| Risk | Impact | Mitigation | Owner |
|---|---|---|---|
| Delay in Reference Product Procurement | High | Initiate early sourcing | Ravi Desai |
| Site Unavailability | Medium | Identify alternate CRO | Neha Patil |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/02/2022 | 1.0 | Initial Release | New SOP | QA Head |
| 17/04/2025 | 2.0 | Revised format, updated procedures, new annexures | Annual SOP Review | QA Head |