Protocol for Blood Sample Collection in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the collection, handling, and processing of pharmacokinetic (PK) blood samples in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the planning, collection, handling, and analysis of PK blood samples, including Clinical Research Associates (CRAs), Study Nurses, Laboratory Personnel, and Data Managers.

Responsibilities

• The Study Coordinator is responsible for coordinating PK sample collection activities and ensuring compliance with the study protocol and regulatory requirements.
• The Study Nurse or Phlebotomist is responsible for collecting blood samples from study participants according to the specified sampling schedule and procedures.
• The Laboratory Personnel are responsible for processing and analyzing PK blood samples, including sample storage, centrifugation, and analysis techniques.

Procedure

1. Develop a PK sampling plan detailing the timing, frequency, and volume of blood samples to be collected based on the study protocol and pharmacokinetic objectives.
2. Train study personnel involved in sample collection on proper phlebotomy techniques, sample handling, and documentation procedures.
3. Coordinate with study participants to schedule PK sampling visits and provide clear instructions on fasting requirements, medication restrictions, and other relevant instructions.
4. Collect blood samples using aseptic techniques and appropriate collection devices, ensuring