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

1. Obtain product development briefing and determine BA/BE requirement based on regulatory strategy.
2. Check for available product-specific guidance documents (e.g., USFDA PSG, EMA Guideline).
3. Review reference product literature including SmPC, FDA Label, or equivalent.
4. Confirm reference product availability in intended regulatory markets.

5.2 Stakeholder Meeting and Kickoff

1. Organize a cross-functional kickoff meeting including representatives from Clinical, Regulatory, QA, Bioanalytical, and Formulation teams.
2. Establish key planning deliverables and timelines.
3. Document all meeting minutes and circulate with action items.

5.3 Drafting of Study Synopsis

1. Develop study synopsis including objectives, study design (fasted/fed), proposed dosage, and analytical approach.
2. Align synopsis with regulatory guidance and submit for internal review and approval.
3. Include statistical methodology outline for endpoint analysis.

5.4 Study Design Considerations

1. Select appropriate study design: crossover, parallel, replicate, or single-dose.
2. Document justification for design choice in the synopsis.
3. Plan washout period, sample size, and dosing conditions.

5.5 Resource and Site Planning

1. Identify qualified CROs or clinical sites experienced in BA/BE studies.
2. Initiate vendor qualification and feasibility check.
3. Evaluate study conduct timeline with selected site.

5.6 Regulatory Pathway Evaluation

1. Check if pre-submission meetings are required with CDSCO, USFDA, EMA, etc.
2. Plan for necessary submissions such as Form 44 (India), IND/ANDA (US), or EudraCT registration (EU).
3. Prepare draft Gantt chart with projected timelines for protocol finalization, ethics submission, and first subject dosing.

5.7 Risk and Contingency Planning

1. Perform preliminary risk identification including volunteer recruitment, analytical turnaround, and product procurement delays.
2. Develop mitigation plans and include in the risk register.
3. Schedule periodic review meetings to track planning progress.

5.8 Documentation and Approval

1. Compile planning package: study synopsis, regulatory roadmap, risk register, and kickoff meeting minutes.
2. Route documents for internal QA and management approvals.
3. 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

1. Study Planning Checklist – Annexure-1
2. Study Synopsis Template – Annexure-2
3. 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