🇦🇫 Bioavailability & Bioequivalence (BA/BE) Studies Services for Afghanistan
ANMHPA-Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA) and Bioequivalence (BE) services, along with Comparative Dissolution Profiling, customized for regulatory submissions to Afghanistan’s ANMHPA – Afghanistan National Medicines and Healthcare Products Authority.
Since Afghanistan’s regulatory system relies strongly on international frameworks, our services comply with:
ANMHPA requirements for generic medicines & dossier submissions
WHO TRS guidelines for Bioequivalence Studies
ICH Guidelines (E6 R2, Q2, Q6A, M10)
EMA Bioequivalence Guideline (used as international reference)
GCP, GLP & GMP global standards
USP / Ph. Eur. dissolution quality standards
This ensures your BA/BE data is globally recognized and suitable for Afghanistan’s reliance-based regulatory assessments.
💊 Core BA/BE Services for Afghanistan (ANMHPA-Aligned)
Clinical BA/BE Studies (Human)
• Conducted according to WHO, ICH, and EMA BE scientific principles, recognized by Afghanistan’s regulatory authority.
• Single-dose & multiple-dose studies using crossover or parallel designs.
• Healthy volunteers or special patient groups where required.
• Ethical approvals according to international GCP standards.
• Protocols developed following ICH E6 (R2) and WHO TRS BE principles.
Comparative Dissolution Profiling (CDP)
• Required for generic medicine applications and dossier evaluations in Afghanistan.
• Dissolution per USP / Ph. Eur. and biorelevant media.
• Similarity factor (f2) analysis for dissolution equivalence.
• Model-independent and model-dependent dissolution comparison methods.
IVIVC & Biowaiver Support
• BCS-based biowaiver justification per WHO TRS, EMA, and ICH Q6A.
• Level A, B, and C IVIVC modeling to correlate dissolution with PK outcomes.
• Suitable for BCS Class I & III medicines.
Analytical Method Development & Validation
• LC-MS/MS & HPLC-UV bioanalytical method development.
• Full validation per ICH M10, acceptable to ANMHPA.
• Stability-indicating analyses for APIs and finished dosage forms.
• Validation parameters: precision, accuracy, linearity, specificity & stability.
Pharmacokinetic (PK) & Bioequivalence Statistical Analysis
• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• Standard international BE criteria: 90% CI within 80–125%.
• Scaled BE methodology for Highly Variable Drugs (HVDs) when justified.
• Power and sample-size estimations for optimal study design.
📑 ANMHPA-Ready Dossier & Regulatory Documentation
We prepare complete submission-ready documentation tailored for Afghanistan’s requirements:
• Clinical Study Protocol
• Informed Consent Forms (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) following ICH E3 structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5, including:
Module 1 adapted for Afghan regulatory requirements
Bioequivalence evidence for generic medicine registration
Stability & quality documentation to support submission
✨ Why Choose BioEquiGlobal for Afghanistan?
• Internationally Recognized Data Standards: BE packages accepted by ANMHPA due to WHO/ICH alignment.
• Global Quality Systems: GCP-, GLP-, and GMP-compliant processes ensure reliable and credible data.
• Experience with Emerging Regulatory Markets: Ideal for manufacturers entering Afghanistan and nearby regions.
• Support for Standard & Complex Formulations: MR products, injectables, ophthalmics, inhalation, topicals & HVDs.
• End-to-End Regulatory Support: From feasibility to final CTD preparation.
🗺️ BA/BE Study Workflow for Afghanistan
Feasibility & International Guideline Mapping
(Reference product review, WHO/ICH guideline alignment, biowaiver assessment)Protocol Development & Ethics Alignment (GCP)
(Protocols prepared according to WHO/ICH BE standards)Analytical Method Development & Validation
(ICH M10-compliant LC-MS/MS validation)Clinical Study Execution
(Volunteer recruitment, dosing & PK sampling under strict GCP)Bioanalysis & PK/BE Statistical Evaluation
(NCA, BE assessment, scaled BE for HVDs where appropriate)ANMHPA-Ready CTD Documentation
(CSR, CDP, analytical validation & full dossier support)
Who We Support in Afghanistan & Internationally
• Generic pharmaceutical manufacturers
• Companies exporting to Afghanistan & Central Asia
• CROs requiring BA/BE or bioanalytical outsourcing
• Regulatory teams preparing CTD submissions
• Specialty pharma & biotech innovators
• International manufacturers entering new markets