🇵🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for Panama

Panama's regulatory strategy for generic drugs is based on the principle of ensuring Therapeutic Equivalence and relies heavily on international data and decisions, especially through its recent regulatory reforms.

1. The Expedited Registration Pathway (Reliance)

Recent legislation (Law 419 of 2024 and Executive Decree No. 2 of 2025) introduced an expedited registration process for medicines approved in countries with High Standard Countries (HSCs) or those whose regulatory authorities are on the WHO List of Authorities (WLA).

• Principle: This reliance pathway allows for the automatic recognition of sanitary registrations granted by these recognized authorities.

• Impact on BE: For products approved via this mechanism, the DNFD relies on the foreign regulatory authority's decision regarding Bioequivalence (BE) and interchangeability, thereby eliminating the need for prior local laboratory analysis or redundant evaluations.

2. Standard Registration Pathway (In-Depth Review)

For products not eligible for the expedited pathway, the standard sanitary registration process requires comprehensive documentation to demonstrate safety, efficacy, and quality.

💊 Core Requirements for Generic Drugs

• Mandatory Equivalence: Generic products must provide evidence of Therapeutic Equivalence. This is achieved by submitting an in vivo Bioequivalence (BE) study or an acceptable Biowaiver.

• Data Acceptance: The DNFD accepts BE studies that comply with recognized international standards such as those from the WHO (World Health Organization) and the ICH (International Council for Harmonisation).

• Study Design: If required, the in vivo study must be the randomized, single-dose, two-period, two-sequence, crossover study in healthy adult subjects, adhering to Good Clinical Practice (GCP) standards.

• Acceptance Criteria: Statistical analysis of the pharmacokinetic (PK) parameters, Area Under the Curve ($\text{AUC}$) and Maximum Concentration ($\text{C}_{\text{max}}$), must show the $90\%$ Confidence Interval (CI) for the geometric mean ratio of the test to reference product falls within the standard international range of $80.00\%$ to $125.00\%$.

Biowaivers and Comparative Dissolution Profiling (CDP)DNFD / MINSA–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Panama’s pharmaceutical regulatory requirements under:

• Ministerio de Salud (MINSA)

• Dirección Nacional de Farmacia y Drogas (DNFD)

All studies are conducted in line with DNFD guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for Panama’s national regulatory submissions and broader Central American market approvals.

💊 Core Services for Panama (DNFD / MINSA) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose BE studies in crossover or parallel designs recognized by DNFD.
• Volunteer Selection: Healthy volunteers or patient-specific groups depending on therapeutic indications.
• Ethics Approval: Mandatory approval from a Comité de Bioética de Investigación (CBI) accredited in Panama.
• Protocol Development: Designed per ICH E6 (R2) GCP, WHO TRS, and DNFD regulatory requirements.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for generic pharmaceuticals, formulation variations, and equivalence assessment.
• Dissolution Media: Pharmacopeial and biorelevant media accepted by DNFD.
• Similarity Factor: f2 similarity factor for dissolution curve comparison.
• Evaluation Approaches: WHO/ICH-compliant model-independent (f1, f2) and model-dependent methods.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS and ICH Q6A guidelines, suitable for DNFD submissions.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports regulatory justification for biowaivers and optimized BE planning.

Analytical Method Development & Validation

• Technologies: LC-MS/MS and HPLC-UV analytical platforms.
• Validation: Per ICH M10, WHO TRS, and DNFD-aligned standards.
• Stability-Indicating Methods: Developed for APIs and finished products.

Pharmacokinetic (PK) Analysis

• PK Approach: Non-compartmental PK analysis (NCA).
• BE Statistics: Conducted using WHO/ICH harmonized statistical methodologies.
• Sample Size & Power: Scientifically calculated for conclusive BE outcomes.

📑 Panama DNFD–Ready Regulatory Documentation

We prepare complete, Panama-specific regulatory documentation, including:

• Clinical Study Protocol (Panama-compliant)
• Informed Consent Forms (ICF) meeting CBI ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for DNFD submissions

✨ Why Choose BioEquiGlobal for the Panamanian Market?

• Regulatory Expertise: Understanding of DNFD requirements for pharmaceutical and generic drug registration.
• International Quality Compliance: Strict adherence to GCP, GLP, WHO TRS, and ICH standards supported by strong QA systems.
• Advanced Facilities: Accredited clinical units and modern analytical laboratories (including NABL-certified setups).
• Global Submission Support: CTDs prepared for Panama and major regulatory agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Panama

1. Feasibility & Gap Assessment: Evaluate reference product availability, dissolution comparability, and biowaiver opportunities.

2. Protocol Development: Create DNFD-compliant BA/BE protocols and coordinate CBI ethics approval.

3. Analytical Method Development: LC-MS/MS method development & validation per ICH M10 & WHO TRS.

4. Clinical Execution: Conduct clinical studies under GCP with dosing, sampling, and safety monitoring.

5. Bioanalysis & PK Evaluation: Perform PK modeling, QC checks, and BE statistical analysis.

6. Documentation & Submission: Deliver Panama-ready CSR, dissolution report, validation documents, and CTD/ACTD modules.

Who We Support

• Pharmaceutical manufacturers targeting Panama and Central America
• CROs seeking clinical or analytical outsourcing
• Regulatory teams requiring DNFD-compliant CTD/ACTD dossiers

• BCS-Based Biowaiver: Panama generally recognizes the Biopharmaceutics Classification System (BCS)-based Biowaiver concept for low-risk, immediate-release oral solid dosage forms, aligned with WHO and ICH M9 guidelines.

• CDP Requirement: In vitro Comparative Dissolution Studies are mandatory for quality submission and to support Biowaiver requests, using the $f_2$ similarity factor analysis.

📑 DNFD Regulatory Documentation

• Dossier Format: The application is submitted through the Digital Pharmacy and Drugs platform (FADDI) and requires a dossier that closely follows the CTD (Common Technical Document) structure.

• Stability: Stability studies must be conducted according to climatic zone IVb conditions, which apply to Panama.

• Language: Documentation must be in Spanish, or accompanied by a translation by an authorized public translator if technical studies (like the BE report) are in English.

• Post-Market Surveillance: Panama strengthens its Pharmacovigilance system and aligns it with international standards (adopting WHODrug Global and MedDRA dictionaries) to ensure ongoing monitoring of registered products.