🇮🇩 Bioavailability & Bioequivalence (BA/BE) Studies Services for Indonesia
BPOM-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides full-service BA/BE studies and Comparative Dissolution Profiling tailored to Indonesia’s pharmaceutical regulatory requirements, governed by BPOM (Badan POM).
Our studies strictly adhere to ICH guidelines, WHO TRS, ASEAN BA/BE guidelines, GLP, GCP, and the Indonesian BPOM requirements for obtaining national drug registration approvals and supporting export submissions.
💊 Our Core Services for Indonesia Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs as required by BPOM.
• Volunteer Selection: Healthy volunteers or patient groups as per BPOM guidance and ethical requirements.
• Ethics Approval: Review and approval by an accredited Komite Etik Penelitian Kesehatan (KEPK) or Institutional Ethics Committee in Indonesia.
• Protocol Development: Protocols aligned with ICH E6 (R2) GCP, WHO TRS, and ASEAN/Common Technical Requirements recognized by BPOM.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic drug registration, post-approval variations, and bio-waiver submissions under BPOM regulations.
• Media: Biorelevant and pharmacopeial dissolution media as per BPOM and ASEAN standards.
• Similarity Analysis: f2 similarity factor used to compare dissolution profiles of test and reference products.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent dissolution modeling approaches.
IVIVC & Biowaiver Support
• Biowaiver Preparation: BCS-based biowaiver documentation following BPOM, WHO TRS, and ASEAN guidelines.
• IVIVC Modeling: Level A, B, and C IVIVC models to justify in vitro–in vivo predictability.
• Predictive PK Modeling: Advanced dissolution–PK correlation for regulatory acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV methods designed for sensitive and selective quantification.
• Validation: Conducted as per ICH M10, WHO, and BPOM bioanalytical method validation rules.
• Stability-Indicating Methods: Development of stability methods for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental analysis (NCA) for BE evaluation.
• Statistical BE Assessment: Bioequivalence statistical evaluation aligned with ICH, WHO, and BPOM expectations.
• Sample Size Optimization: Power calculations and study design support tailored to BPOM requirements.
📑 BPOM-Ready Regulatory Documentation
We prepare complete documentation packages tailored to Indonesia’s BPOM drug registration system:
• Clinical Study Protocol (ICH- and BPOM-aligned)
• Informed Consent Forms (ICF) fitting Indonesian ethical and regulatory requirements
• Investigator Brochure
• Clinical Study Report (CSR) per ASEAN + ICH format accepted by BPOM
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD modules prepared according to BPOM’s pharmaceutical product registration requirements
✨ Why Choose BioEquiGlobal for the Indonesian Market?
• Indonesia-Focused Compliance: Study protocols and reports aligned with BPOM, ASEAN, WHO, and ICH guidelines.
• Quality Assurance: Strict adherence to internationally recognized GCP and GLP standards with internal QA audits.
• Trusted Infrastructure: Accredited clinical units and high-quality analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Strength: Dossiers prepared not only for BPOM Indonesia but also for US FDA, EMA, GCC, TGA, MHRA, and other global agencies.
🗺️ Our BA/BE Study Workflow for Indonesia
Feasibility & BPOM Gap Assessment: Evaluation of reference product, Indonesian market equivalents, and BCS/biowaiver eligibility.
Protocol Development: Preparation of BPOM-appropriate BA/BE protocols and assistance with KEPK ethics committee submission.
Analytical Method Development: LC-MS/MS method design and validation per ICH M10, WHO, and BPOM requirements.
Clinical Study Execution: GCP-compliant dosing, sampling, and monitoring of subjects.
Bioanalysis & PK Assessment: Full analytical execution, QC verification, PK modeling, and statistical bioequivalence testing.
Documentation & Submission: Preparation of BPOM-ready CSR, method validation reports, dissolution analysis, and CTD/ACTD submission packages.
Who We Support
• Indonesian pharmaceutical companies seeking BPOM product registration
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing BPOM-compliant CTD/ACTD dossiers for drug registration