🇮🇱 Bioavailability & Bioequivalence (BA/BE) Studies Services for Israel

Israeli Ministry of Health (MoH / AMAR)–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA) and Bioequivalence (BE) studies, as well as Comparative Dissolution Profiling, tailored to the regulatory requirements of Israel for pharmaceutical registrations under the Department of Pharmaceuticals (AMAR), Ministry of Health (MoH).

Our BA/BE studies align with:

• Israeli Ministry of Health (MoH) / AMAR Guidelines for Bioequivalence

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

• WHO TRS & internationally harmonized BE principles

• GCP, GLP & GMP (Israel-adopted international standards)

• USP / Ph. Eur. dissolution methods

Israel’s high scientific standards and regulatory rigor require globally acceptable, well-structured BA/BE packages—ideal for both local filings and international submissions.

💊 Core BA/BE Services for Israel (MoH/AMAR)

Clinical BA/BE Studies (Human)

• Conducted according to MoH/AMAR BE guidelines & international GCP.
• Single-dose & multiple-dose BE studies (crossover or parallel design).
• Healthy volunteer studies or patient-based studies depending on indication.
• IRB/Helsinki Committee approvals per Israeli clinical trial regulations.
• Protocols aligned with ICH E6 (R2) and MoH expectations regarding PK endpoints.

Comparative Dissolution Profiling (CDP)

• Required for Israeli Generic (copy drug) and Similar drug submissions.
• Dissolution per USP / Ph. Eur. and MoH-recommended conditions.
• Similarity factor (f2) calculations for dissolution equivalence.
• Model-independent & model-dependent release profile analyses.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification aligned with ICH Q6A, WHO TRS, and MoH requirements.
• Level A/B/C IVIVC modeling to predict in vivo behavior.
• Biowaiver suitability for BCS Class I & III drugs when justified.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV based bioanalytical and dissolution methods.
• Method validation following ICH M10 (recognized by MoH).
• Stability-indicating method development for APIs and finished products.
• Comprehensive validation: accuracy, precision, selectivity, linearity & stability.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• Standard BE acceptance range for most drugs: 80–125% (90% CI).
• Support for highly variable drugs (HVDs) using acceptable scientific approaches.
• Sample-size and power calculations adhering to MoH BE guidelines.

📑 Israel MoH (AMAR)–Ready Regulatory Documentation

We prepare complete documentation packages ready for Israeli submission:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) compliant with MoH + ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules (ICH format) adapted to Israel’s regulatory structure

This documentation supports:

• New Generic Drug Applications

• Similar Drug Applications

• Variations requiring BE support

✨ Why Choose BioEquiGlobal for Israel?

• MoH/AMAR Regulatory Expertise: Study designs are aligned with Israel’s specific BE expectations.
• Global Acceptability: GCP/GLP/GMP-based operations ensure international-quality data suitable for MoH and global submissions.
• Strong Scientific Infrastructure: Experience with complex dosage forms (MR, ophthalmic, topical, inhalation, injectables).
• End-to-End Support: From feasibility, study protocol drafting & execution to PK/BE analysis and CTD dossier preparation.
• Adapted for Israel + Export: BE packages prepared for Israel are easily expandable for EU, USFDA, GCC, and other global markets.

🗺️ BA/BE Study Workflow for Israel

1. Feasibility & Regulatory Assessment
   (Reference selection, MoH guidelines mapping, biowaiver eligibility)

2. Protocol Development & IRB/Helsinki Committee Approval
   (MoH clinical trial regulatory compliance)

3. Analytical Method Development & Validation
   (ICH M10-compliant LC-MS/MS validation)

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

5. Bioanalysis & PK/BE Statistical Evaluation
   (NCA PK modeling, BE conclusion per MoH requirements)

6. MoH/AMAR-Ready CTD Documentation
   (CSR, CDP, analytical validation & full CTD Modules)

Who We Support in Israel

• Israeli pharmaceutical manufacturers
• International companies entering the Israel market
• CROs outsourcing bioanalytical/PK work
• Innovators reformulating products for MoH approval
• Export-oriented pharma companies seeking harmonized BE packages
• Specialty, biotech & complex generics developers