🇰🇭 Bioavailability & Bioequivalence (BA/BE) Studies Services for Cambodia
DDF-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete BA/BE study and Comparative Dissolution Profiling services tailored to Cambodian regulatory requirements, governed by the Department of Drugs and Food (DDF), Ministry of Health, Cambodia.
Our studies strictly follow GCP, GLP, WHO TRS, ICH, and regional ASEAN guidelines to support pharmaceutical companies in obtaining drug registration approvals for both Cambodian and international markets.
💊 Our Core Services for Cambodia Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Design: Single-dose and multiple-dose BA/BE studies, using crossover or parallel designs recognized by the DDF.
• Volunteer Selection: Healthy volunteer participation or patient-based studies as appropriate to the Cambodian regulatory and ethical framework.
• Ethics Approval: Review and approval by a Cambodian National Ethics Committee for Health Research (NECHR) or equivalent institutional ethics committee.
• Protocol Development: Protocols aligned with ICH E6 (R2) GCP, ASEAN BA/BE guidelines, WHO TRS, and DDF requirements.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic drug registration and variation submissions under DDF and ASEAN guidelines.
• Media: Use of biorelevant and pharmacopeial dissolution media.
• Analysis: Calculation of similarity factor (f2) for comparing test and reference product profiles.
• Comparison Methods: Includes model-independent (f1, f2) and model-dependent mathematical modeling.
IVIVC & Biowaiver Support
• Biowaiver Justification: BCS-based biowaiver support compliant with DDF, WHO TRS, and ASEAN harmonized requirements.
• Modeling: Development of Level A, B, and C IVIVC models for regulatory predictions.
• PK Prediction: Use of dissolution–PK modeling to strengthen regulatory submissions.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV bioanalytical methods suited for DDF BA/BE requirements.
• Validation: Conducted according to ICH M10, ASEAN, WHO, and recognized international standards.
• Stability: Stability-indicating method development for APIs and finished formulations.
Pharmacokinetic (PK) Analysis
• PK Type: Non-compartmental PK analysis (NCA) for BA/BE studies.
• BE Statistics: Statistical evaluation of bioequivalence following ICH and ASEAN guidelines accepted by the DDF.
• Study Design Optimization: Power and sample-size calculations for achieving regulatory compliance.
📑 DDF-Ready Regulatory Documentation
We prepare complete documentation tailored for submission to the Department of Drugs and Food (DDF), Ministry of Health Cambodia:
• Clinical Study Protocol (DDF- and ASEAN-aligned)
• Informed Consent Forms compliant with Cambodian ethics requirements
• Investigator Brochure
• Clinical Study Report (CSR) prepared following ASEAN & ICH structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD modules structured for DDF drug registration requirements
✨ Why Choose BioEquiGlobal for the Cambodian Market?
• Cambodia-Focused Regulatory Expertise: Protocols and submissions aligned with DDF guidelines and ASEAN harmonized pharmaceutical regulatory frameworks.
• Strong Quality Assurance: SOP-based operations with internal QA audits following global GCP and GLP best practices.
• Reliable Infrastructure: Accredited clinical facilities and advanced analytical laboratories (including NABL-certified labs where applicable).
• International Submission Capability: Dossiers prepared for DDF, US FDA, EMA, GCC, MHRA, TGA, and other global agencies.
🗺️ Our BA/BE Study Workflow for Cambodia
Feasibility & Regulatory Gap Assessment: Evaluation of biowaiver eligibility, reference product requirements, and ASEAN/DDF alignment.
Protocol Development: Drafting of DDF-compliant BA/BE protocol and securing ethics approval from NECHR or institutional committee.
Analytical Method Development: LC-MS/MS method design and validation as per ICH M10, WHO TRS, and ASEAN norms.
Clinical Study Execution: Conduct of dosing and sampling under strict GCP-compliant supervision.
Bioanalysis & PK Assessment: QC-verified bioanalysis, PK modeling, and statistical BE evaluation.
Documentation & Submission: Preparation of DDF-ready CSR, bioanalytical reports, dissolution comparisons, and CTD/ACTD dossier modules.
Who We Support
• Cambodian pharmaceutical manufacturers and importers seeking DDF product registration
• CROs requiring BA/BE study execution or analytical outsourcing
• Regulatory teams needing DDF-compliant CTD/ACTD documentation