Laboratory Services Method Development & Validation

  • Research type

    Research Study

  • Full title

    An Open-Label, Single-Centre Scientific Evaluation of Approved Medicinal Products in Healthy Participants for the Purpose of Validating MAC’s Safety and Bioanalytical Laboratories to Support the Application for ISO17025 Accreditation



  • Contact name

    Charles Garasi

  • Contact email

  • Sponsor organisation

    MAC Clinical Research

  • Duration of Study in the UK

    0 years, 2 months, 19 days

  • Research summary

    MAC Clinical Research intends to conduct a scientific evaluation on human participants to verify the pharmacological effects and/or properties of several commercially available over the-counter (OTC) medicinal products (MPs). The aim of this study is to investigate MAC’s in house bioanalytical and safety laboratories in their ability to produce evaluable pharmacokinetic (PK) and safety data. The safety data produced will be compared to data produced by an accredited, third-party safety laboratory which will be contracted to analyse the same samples. The PK and metabolite data will be compared to validated literature values. The validity of these data will be evaluated statistically and will be used to support an application for ISO71025 accreditation.

    This is an open label study of approved Medicinal products, administered in 35 healthy participants. It is planned to enrol 35 participants into 7 cohorts, each consisting of 5 participants. Participants in each cohort will be administered a single dose of 1 of 7 different approved and commercially available over the counter medications as per the manufacturers recommended dosage.

  • REC name

    East of England - Essex Research Ethics Committee

  • REC reference


  • Date of REC Opinion

    21 Dec 2023

  • REC opinion

    Further Information Favourable Opinion