Explore our comprehensive collection of ready-to-use bioequivalence study protocols designed to accelerate your generic drug development and streamline regulatory approval pathways. Each protocol is meticulously crafted to meet FDA and EMA requirements, providing detailed study designs, pharmacokinetic parameters, and statistical methodologies tailored to each molecule’s unique characteristics.

Study Design Framework

Each protocol includes a molecule-specific study design, developed with careful consideration of pharmacokinetics, variability, dosage form, and applicable regulatory guidance. This includes:

• Study type and design
• Dose strength and administration conditions
• Washout period justification
• Risk–benefit assessment

The study designs are structured to reliably capture intra- and inter-subject variability and to support robust bioequivalence conclusions.

Comprehensive Pharmacokinetic Framework

Each protocol provides a detailed pharmacokinetic (PK) assessment plan, including:

• Defined primary and secondary PK parameters 
• Blood sampling schedules optimized for both absorption and elimination phases

This framework ensures alignment with regulatory expectations for accurate and reliable exposure assessment.

Statistical Considerations Aligned with Regulatory Standards

Protocols include a clearly defined statistical analysis plan, covering:

• Bioequivalence acceptance criteria 
• Appropriate statistical models 
• Handling of dropouts 
• Population definitions 

The statistical approach is designed to meet FDA and EMA review standards.

Protocol Overview & Regulatory Positioning

Each protocol is a fully developed BE study protocol intended to support ANDA and global generic submissions, and includes:

• Alignment with FDA Product-Specific Guidance 
• Design to demonstrate bioequivalence between the Test product and Reference Listed Drug (RLD)
• Compliance with:
  • ICH E6 (R3) Good Clinical Practice
  • FDA regulations 
  • EMA bioequivalence guidelines
• Structured for IRB/ IEC submission with minimal customization
• Suitable for U.S. and international regulatory filings

Safety Monitoring & Risk Management

Each protocol incorporates a comprehensive safety assessment plan, including:

• Monitoring and reporting of adverse events (AEs) and serious adverse events (SAEs)
• Vital signs, ECGs, and clinical laboratory evaluations
• Molecule-specific safety considerations
• Subject-level and study-level stopping rules
• End-of-study and follow-up safety assessments

Operational Readiness

Our protocols go beyond regulatory requirements and include practical execution details, such as:

• Screening and eligibility assessments
• Check-in, dosing, and confinement procedures
• Activity, dietary, and compliance restrictions
• Sample handling and bioanalytical method compliance requirements

This ensures smooth implementation at clinical sites or CROs.

Quality Assurance & Inspection Readiness

Each protocol incorporates quality and compliance elements to support inspection readiness, including:

• Monitoring and audit preparedness
• Source documentation expectations
• Data handling, archival, and retention requirements
• Traceability aligned with FDA and EMA inspection standards