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

NMPA / CDE–Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies and Comparative Dissolution Profiling, designed fully in accordance with China’s regulatory expectations under the NMPA and CDE.

China requires BE studies for generic drug registration under its Generic Quality and Efficacy Consistency Evaluation Program, one of the most rigorous systems in Asia.

Our BE studies comply with:

• NMPA Guidelines for Bioequivalence Studies

• CDE Technical Requirements for Generic Drug Consistency Evaluation

• ICH Guidelines (E6 R2, E8 R1, Q2, Q6A, M10)

• China GCP (2020 Revision)

• China GLP & China GMP

• ChP (Chinese Pharmacopoeia) Dissolution Standards

• WHO & EMA BE scientific references where applicable

This ensures your BE study data meets China’s high standards and international harmonization requirements.

💊 Core BA/BE Services for China (NMPA/CDE-Aligned)

Clinical BA/BE Studies (Human)

• Conducted per NMPA/CDE requirements and China GCP (2020).
• Single-dose and multiple-dose BE studies using crossover/parallel designs.
• Healthy volunteer studies; patient-based PK for special formulations.
• Ethical approval via certified Institutional Review Boards (IRBs).
• Protocols fully aligned with NMPA BE guidelines & ICH E6 (R2).

Comparative Dissolution Profiling (CDP)

• Mandatory under China’s Generic Drug Consistency Evaluation.
• Dissolution performed as per ChP, USP, EP, and biorelevant media.
• Similarity factor f2, discrimination testing, and kinetic modeling.
• Supports both IR and MR formulations.

IVIVC & Biowaiver Support

• Based on CDE/ICH guidelines and WHO TRS where applicable.
• Level A/B/C IVIVC modeling for dissolution–PK predictability.
• BCS-based biowaiver justification for eligible APIs (primarily Class I).

Analytical Method Development & Validation

• LC-MS/MS and HPLC-UV method development tailored for Chinese regulatory standards.
• Validation per ICH M10 and CDE bioanalytical requirements.
• Stability-indicating assay development for APIs & finished products.
• Full validation: accuracy, precision, selectivity, linearity, recovery & stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK calculations (AUC, Cmax, Tmax, t½).
• NMPA/ICH-standard BE acceptance criteria: 90% CI within 80–125%.
• Scaled BE for Highly Variable Drugs (HVDs) accepted with justification.
• Sample-size & power analysis performed per CDE expectations.

📑 NMPA / CDE Submission-Ready Documentation

We prepare full submission documentation aligned to Chinese CTD requirements:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3 + CDE format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile (CDP) Report
• China-CTD Modules 1–5, including:

• Module 1: Chinese administrative & legal requirements

• Module 2–5: Full quality, nonclinical & clinical documentation

• Consistency Evaluation reports for generics

✨ Why Choose BioEquiGlobal for China?

• NMPA/CDE-Aligned Expertise: Ensures studies meet China’s highest regulatory standards.
• Designed for Consistency Evaluation: Supports China’s stringent generic drug quality reform.
• International Quality Systems: GCP/GLP/GMP-compliant processes ensure global acceptance.
• Ideal for China + Global Markets: Dossiers structured for China, USFDA, EMA, WHO PQ, GCC, TGA and more.
• Specialization in Complex BE: MR products, HVDs, injectables, ophthalmics, inhalation, topicals & peptide-based medicines.

🗺️ BA/BE Study Workflow for China (NMPA/CDE Submissions)

1. Feasibility & Chinese Regulatory Mapping
   (Reference product identification, BE pathway, biowaiver assessment)

2. NMPA-Aligned Protocol Development & IRB Approval
   (China GCP 2020 + ICH E6 compliant)

3. Analytical Method Development & Validation
   (ICH M10 + CDE bioanalytical requirements)

4. Clinical Study Execution
   (Volunteer recruitment, dosing, PK sampling under certified Chinese GCP standards)

5. Bioanalysis & PK/BE Statistics
   (NCA, BE calculations, scaled BE for HVDs)

6. China-CTD Documentation Preparation
   (CSR, CDP, validation package & CTD Modules 1–5)

Who We Support in China & Internationally

• Chinese generic manufacturers undergoing Consistency Evaluation
• Global companies entering the China pharmaceutical market
• CROs in China needing BA/BE partnerships
• Export-oriented pharma targeting Asia
• R&D teams reformulating products for China
• Specialty pharma & biotech firms