Our Service

BA & BE Studies

Ensure full EU and global regulatory compliance for your medical products with expert guidance.

Overview

Bioavailability (BA) and Bioequivalence (BE) studies are critical for generic drug approval and formulation development. Globaxa coordinates comprehensive BA/BE studies that meet global regulatory requirements, ensuring your products demonstrate appropriate pharmaceutical equivalence for market authorization.

BA/BE Study Services

Study Design & Protocol Development

Study design based on regulatory guidance (FDA, EMA, WHO)
Crossover versus parallel design selection
Sample size calculation
Sampling time point optimization
Food effect study design
Fasting versus fed state protocols
Single-dose versus steady-state studies
Replicate design for highly variable drugs

Regulatory Compliance

FDA Bioequivalence Guidance compliance
EMA Bioequivalence Guideline adherence
WHO prequalification requirements
Country-specific regulatory standards
Protocol approval from authorities
Ethics committee submissions

Our Comprehensive BA/BE Services

Globaxa provides end-to-end support for bioavailability and bioequivalence studies, managing every aspect from initial concept through final regulatory submission. Our integrated approach ensures seamless coordination across all study phases while maintaining the highest standards of scientific rigor and regulatory compliance. We work closely with pharmaceutical sponsors to understand their specific requirements, timelines, and budget constraints, developing customized solutions that optimize study design while minimizing risk and maximizing the probability of successful outcomes.

Our service portfolio encompasses strategic study planning, where our experienced team evaluates the drug substance characteristics, formulation properties, and regulatory requirements to design optimal study protocols. We conduct thorough feasibility assessments considering factors such as drug half-life, expected variability, subject safety considerations, and analytical method requirements. This upfront planning phase is crucial for identifying potential challenges and implementing appropriate mitigation strategies before study initiation.

Strategic Protocol Development and Regulatory Alignment

The foundation of any successful BA/BE study lies in a well-designed protocol that addresses all scientific, regulatory, and operational requirements. Our protocol development process begins with a comprehensive review of available data on the drug substance, including its pharmacokinetic properties, therapeutic window, known drug interactions, and any special considerations related to food effects or formulation-dependent absorption. We analyze regulatory guidance documents from relevant authorities including the FDA, EMA, WHO, and country-specific agencies to ensure the protocol design meets or exceeds all applicable requirements.

Study design selection represents a critical decision point that impacts study feasibility, statistical power, and overall success probability. For most oral solid dosage forms with relatively short elimination half-lives, we typically recommend randomized, two-period, two-sequence crossover designs that allow each subject to serve as their own control, thereby reducing variability and required sample sizes. However, certain situations may warrant alternative designs such as parallel studies for drugs with very long half-lives, replicate designs for highly variable drug products, or multiple-dose steady-state studies for modified-release formulations.

Sample size determination requires careful consideration of expected within-subject variability, regulatory acceptance criteria, and desired statistical power. We employ sophisticated statistical methods to calculate appropriate sample sizes that provide adequate power to demonstrate bioequivalence while accounting for potential subject dropouts. For highly variable drugs where intra-subject coefficient of variation exceeds certain thresholds, we design replicate studies that allow for expanded acceptance criteria or reference-scaled average bioequivalence approaches as permitted by regulatory guidelines.

Regulatory Submission Support and Documentation

The culmination of BA/BE studies is the preparation of comprehensive study reports suitable for regulatory submission. These reports follow standardized formats specified by regulatory authorities, typically organized according to ICH Common Technical Document structure. The clinical study report provides detailed documentation of all aspects of study design, conduct, analysis, and conclusions, supported by extensive appendices containing protocols, amendments, informed consent forms, investigator credentials, analytical methods and validation reports, statistical analysis plans, subject data listings, and additional supporting documentation.

Our regulatory writing team prepares submission-ready study reports that meet the documentation standards expected by health authorities. We ensure consistency across all report sections, accuracy of data presentations, appropriate cross-referencing of supporting documents, and clear presentation of bioequivalence conclusions. The reports undergo rigorous quality review to verify completeness, accuracy, and compliance with applicable guidelines before finalization. We also prepare responses to potential regulatory questions, drawing on our extensive experience with health authority interactions to anticipate likely areas of inquiry.

Integration of BA/BE data into broader regulatory submissions requires coordination with dossier compilation activities. We work closely with regulatory affairs teams to ensure bioequivalence data is appropriately presented within Module 5 of the Common Technical Document and correctly summarized in Module 2 clinical overviews. Our team assists with preparation of justifications for study design choices, explanations of any protocol deviations, and responses to deficiencies or questions raised by reviewing authorities.

For abbreviated new drug applications and generic drug submissions, bioequivalence data typically represents the primary evidence supporting approval. We assist sponsors in developing submission strategies that optimize approval timelines, including identification of appropriate reference products, assessment of regulatory pathways in different markets, and determination of whether additional studies beyond standard bioequivalence may be required such as food effect studies or studies in special populations.