🇩🇿 Bioavailability & Bioequivalence (BA/BE) Studies Services for Algeria
ANPP-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory requirements of Algeria’s National Agency for Pharmaceutical Products (ANPP) under the Ministry of Pharmaceutical Industry (MIP).
All studies strictly comply with ICH, WHO TRS, GCP, GLP, and Algeria’s pharmaceutical registration standards, ensuring compliance for national submissions and international markets.
💊 Core Services for Algeria (ANPP) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by ANPP.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic indication.
• Ethics Approval: Approval from a recognized Ethics Committee (Comité d’Éthique) as required by Algerian regulations.
• Protocol Development: ANPP-aligned protocols developed in accordance with ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration and variation submissions under ANPP guidelines.
• Dissolution Media: Pharmacopeial and biorelevant media according to Algerian and WHO standards.
• Similarity Factor: Calculation of f2 similarity factor for dissolution comparison.
• Evaluation Techniques: Model-independent (f1, f2) and model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to ICH Q6A, WHO TRS, and ANPP-accepted scientific principles.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Dissolution–PK analysis supporting regulatory justification.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical technologies for drug quantification.
• Validation: Conducted as per ICH M10, WHO TRS, and bioanalytical standards acceptable to ANPP.
• Stability Studies: Stability-indicating method development for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental analysis (NCA).
• BE Statistical Evaluation: Aligned with WHO and ICH harmonized standards recognized by ANPP.
• Power & Sample Size Calculations: Designed to ensure conclusive BE demonstration for Algerian submissions.
📑 ANPP-Ready Regulatory Documentation
We prepare complete regulatory dossiers for submission to Algeria’s National Agency for Pharmaceutical Products (ANPP), including:
• Clinical Study Protocol (Algeria-compliant)
• Informed Consent Forms (ICF) per Algerian ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5 formatted for ANPP drug registration requirements
✨ Why Choose BioEquiGlobal for the Algerian Market?
• Regulatory Precision: All BA/BE study protocols, dissolution profiles, PK analyses, and dossier documentation meet ANPP requirements.
• High Compliance: GCP-, GLP-, WHO-, and ICH-based operational standards with internal QA oversight.
• Advanced Clinical & Analytical Infrastructure: Accredited clinical units and high-precision analytical laboratories (including NABL-certified labs where applicable).
• International Dossier Experience: Expertise in preparing CTD submissions for ANPP and global authorities including US FDA, EMA, MHRA, GCC, TGA, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Algeria
Feasibility & Gap Assessment: Review of Algerian reference products, dissolution requirements, and biowaiver eligibility.
Protocol Development: Preparation of ANPP-compliant BA/BE protocols and facilitation of Ethics Committee approval.
Analytical Method Development: LC-MS/MS method validation following ICH M10 and WHO TRS guidelines.
Clinical Study Execution: GCP-supervised volunteer recruitment, dosing, sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical evaluation.
Documentation & Submission: Preparation of ANPP-ready CSR, dissolution report, validation documents, and CTD Modules 1–5.
Who We Support
• Algerian pharmaceutical manufacturers seeking ANPP approval
• CROs requiring BA/BE or analytical outsourcing
• Regulatory teams needing ANPP-compliant CTD dossiers