🇨🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for China

NMPA-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific division of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored for pharmaceutical companies, CROs, and formulation developers seeking regulatory approval in China.

Our workflows strictly follow:

• NMPA (National Medical Products Administration)

• CDE (Center for Drug Evaluation) Technical Guidelines

• ICH Guidelines (China is an ICH member)

• GCP (2020 Revision, China) & GLP

• Pharmacopoeia of the People’s Republic of China (ChP)

We support both China domestic filing and international regulatory submissions including USFDA, EMA, MHRA, TGA, Health Canada, and others.

💊 Core Services for NMPA Regulatory Submissions

Clinical BA/BE Studies (Human)

• Conducted per NMPA GCP (2020) & CDE BE Guidelines.
• Study types: Single-dose, multiple-dose, crossover & parallel designs.
• Enrollment: Healthy adults or patient populations depending on drug class.
• Ethical review through NMPA-registered Ethics Committees.
• Protocol design compliant with ICH E6 (R2), CDE guidelines & WHO TRS.

Comparative Dissolution Profiling (CDP)

• Required by CDE for generic drug evaluation & post-approval variations.
• Dissolution performed in ChP, USP, EP, and biorelevant media.
• Similarity factor (f2) calculation for profile comparison (mandatory).
• Model-dependent and model-independent release profile evaluation.

IVIVC & Biowaiver Support

• NMPA-recognized BCS-based biowaiver justification.
• IVIVC modeling (Level A/B/C) based on CDE guidance.
• Predictive PK–dissolution correlation for regulatory decision-making.
• Supports waiver of in vivo BE studies where applicable.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical methods designed per ICH M10, the main reference adopted in China.
• Full validation for accuracy, precision, linearity, sensitivity & stability.
• Stability-indicating methods for APIs and finished products.

Pharmacokinetic (PK) & BE Statistical Analysis

• Non-compartmental PK analysis (NCA).
• BE assessment using 90% CI for key PK parameters (AUC, Cmax).
• Power analysis & sample-size estimation per NMPA/CDE recommendations.

📑 NMPA/CDE-Ready Regulatory Documentation

We prepare complete China-focused regulatory documentation:

• Clinical Study Protocol (CSE-compliant)
• Informed Consent Form (Chinese & English versions)
• Investigator Brochure
• Clinical Study Report (CSR) aligned with CDE structure & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules (China follows ICH CTD format) for generic drug applications
• Documents supporting MAH (Marketing Authorization Holder)–based submissions

✨ Why Choose BioEquiGlobal for the Chinese Market?

• True NMPA-Centric Expertise: All protocols and methodologies aligned with Chinese generic drug consistency evaluation and NMPA BE requirements.
• ICH-Integrated Approach: China is fully harmonized with ICH standards—our documentation is globally acceptable.
• Quality Assurance: Internal QA audits, SOP-driven GCP/GLP operations.
• Support for Chinese & International Companies: We offer bilingual documentation to streamline cross-border collaboration.
• Regulatory Robustness: Expertise in navigating CDE review expectations, dissolution equivalence, and BE statistical acceptance criteria.

🗺️ Our BA/BE Workflow for China

1. Feasibility & CDE Gap Assessment
   (Reference selection, Chinese generic consistency evaluation, biowaiver eligibility)

2. Protocol Development & Ethics Approval
   (NMPA-compliant protocol + IEC submission)

3. Analytical Method Development (LC-MS/MS)
   (Validation per ICH M10 adopted by NMPA)

4. Clinical BA/BE Study Execution
   (GCP-compliant dosing, sampling, safety monitoring)

5. Bioanalysis & PK/BE Evaluation
   (Non-compartmental PK + statistical BE assessment)

6. Final Documentation & Submission
   (CSR, bioanalytical validation, dissolution report, CTD package)

Who We Support in China

• Generic drug manufacturers
• MAH system holders (Marketing Authorization Applicants)
• CROs needing specialized analytical or PK/BE outsourcing
• R&D teams preparing for NMPA generic consistency evaluation
• Companies targeting China’s domestic market or export markets