Bioanalysis remains an indispensable part of the drug development process throughout its various stages. Bioanalytical assays play a critical role from the discovery stage up to the final stage of clinical trials, and commercialization.
Clinical bioanalysis, however, refers specifically to the bioanalytical processes involved during the phases of clinical trials.
Clinical Bioanalysis And Clinical Trials CROs
Since the 1990s, it has become increasingly more common to outsource the clinical trial stage to specialist organizations known as contract research organizations (CROs). Also known as clinical trial organizations, these agencies manage all the phases of clinical trials.
Clinical trials CROs ensure regulatory compliance and often facilitate the market authorization procedure.
Why Clinical Bioanalysis Is Critical
The aim of clinical trials is to establish the efficacy and safety of new therapeutics in humans. The clinical trial stage in drug development typically has four phases:
Phase 1: The aim is to establish the PK properties of the new therapeutic, as also the range of safe dosing.
Phase 2: Seeks to demonstrate the efficacy of the new therapeutic, and further substantiate its PK properties.
Phase 3: Aims at gathering supportive evidence in a larger patient population.
Phase 4: Seeks to further substantiate the efficacy and safety claims. This phase also looks for any special drug-to-drug reactions.
Clinical bioanalysis is critical to every phase of drug development for the reasons described below.
Reason # 1: Characterizing PK Disposition In Healthy Human Beings
In the first phase of clinical trials, a new therapeutic gets administered on 20-80 healthy male volunteers. PK testing involves both single and multiple doses.
Reason # 2: Establishing Relative Bioavailability
Another need in the first phase of clinical trials. The aim is to establish the relative bioavailability of the new therapeutic in different formulations: solution/suspension and solid.
Reason # 3: Determining The Food Effect Potential
Bioanalysis during the first phase of clinical trials aims to assess how the proposed new therapeutic interacts with food.
Reason # 4: Assessing Potential Effects On Special Populations
The first phase of clinical trials uses bioanalysis to assess PK dispositions of the new drug in special populations. Children and geriatric individuals, for example.
Reason # 5: Establishing The PK Properties Of The Parent And Its Metabolites
Bioanalysis gets employed in the second phase of clinical trials to establish the PK properties of the parent in patient populations. Also to establish the efficacy of the new drug’s metabolites in plasma, serum, and urine.
Reason # 6: Assessing Standard Drug-Drug Interaction Potential
This is usually in focus in phase 4 of clinical trials, though it sometimes gets studied during phase 3 also.
Bioanalytical assays are necessary to capture possible drug-drug interactions of the new therapeutic and drugs typically prescribed for the targeted patient population.
Reason # 7: Assessing Special Drug-Drug Interaction Potential
Drugs like digoxin, warfarin, etc. have narrow safety margins. Bioanalysis during clinical trial phase 4 is necessary to check the drug-drug reaction potential of the new therapeutic and these drugs.
The Role of Clinical Trials CROs
Clinical CROs act as specialist agencies conducting bioanalytical studies during the clinical trial stage. Their expertise and neutrality increase data credibility.
As per FDA guidelines, however, the ultimate responsibility to ensure quality monitoring and quality assurance remains with the sponsor.