Bio availability testing protocol

Designing a bioavailability testing protocol for a new drug in a plain compressed tablet involves several key steps to ensure that the drug's absorption and availability in the bloodstream are accurately measured. Here's a simplified outline of the protocol 

Photo by Louis Reed on Unsplash 

1. Objective

Primary Goal: To assess the bioavailability of the new drug in a plain compressed tablet form.

Secondary Goal: To compare the bioavailability of the new tablet formulation with a reference formulation if applicable.

2. Study Design

Type: Open-label, single-dose, randomized, crossover study.

Population: Healthy adult volunteers (usually 12-24 subjects).

Dosing: A single oral dose of the test formulation is followed by a washout period, followed by administration of the reference formulation.

3. Inclusion/Exclusion Criteria

Inclusion:

Healthy adults (18-55 years).

BMI within a normal range.

No history of drug or alcohol abuse.

Exclusion:

Allergies to the drug or its components.

Recent participation in another clinical trial.

Any significant health issues affecting drug metabolism or absorption.

4. Dosing and Administration

Dose: The same dose of the drug in the test and reference formulations.

Administration: Oral administration with a standard amount of water, under fasting conditions.

5. Sample Collection

Blood Sampling:

Pre-dose blood sample (baseline).

Post-dose blood samples at various time points (e.g., 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours) to cover the drug's absorption, peak concentration, and elimination phases.

Handling: Blood samples should be processed and stored under conditions that preserve the stability of the drug and its metabolites.

6. Analytical Method

Bioanalytical Assay: Use a validated method such as LC-MS/MS (Liquid Chromatography-Mass Spectrometry) to quantify drug concentrations in plasma.

Validation: The assay should be validated for accuracy, precision, sensitivity, specificity, and reproducibility.

7. Pharmacokinetic Analysis

Parameters: Calculate key pharmacokinetic parameters including Cmax (maximum concentration), Tmax (time to reach Cmax), AUC (area under the concentration-time curve), t1/2 (half-life), and bioavailability (F).

Comparison: If comparing to a reference formulation, assess the relative bioavailability.

8. Statistical Analysis

Bioequivalence Criteria: Use a 90% confidence interval for the ratio of Cmax, AUC0-t, and AUC0-∞ between test and reference formulations. Bioequivalence is typically concluded if the 90% CI falls within the range of 80-125%.

Statistical Methods: ANOVA or non-parametric methods, depending on data distribution.

9. Safety Monitoring

Adverse Events: Monitor subjects for any adverse events or side effects throughout the study.

Vital Signs: Regular monitoring of vital signs (blood pressure, heart rate, etc.).

10. Ethical Considerations

Informed Consent: Obtain written informed consent from all participants.

Regulatory Compliance: Ensure the study complies with local regulatory guidelines (e.g., FDA, EMA) and is approved by an ethics committee.

11. Documentation and Reporting

Study Report: Prepare a comprehensive report detailing the methodology, results, and conclusions.

Regulatory Submission: Submit the bioavailability study report to relevant regulatory authorities as part of the drug approval process.

This protocol provides a structured approach to determine the bioavailability of the new drug in tablet form, ensuring that the drug's performance is thoroughly evaluated.