Guide To Understand How Bioanalysis Helps In Drug Development

The process of development of a new chemical or biological compound revolves in and around the cycle of drug discovery and development. The emergence of the field of bioanalysis has proved to be a critical tool in the life-cycle of any drug product. If you take a keen look at the past decade, our scientists have developed a plethora of assays to check and validate the efficacy of any drug product under analysis. The data procured from the bioanalytical laboratory (anything from drug discovery to pre-clinical programs) has proved to be an excellent rescue for the optimization of all the clinical trials.

What is bioanalysis?

The term ‘bioanalysis’ generally refers to quantitation of either a drug product or any metabolites present in biological fluids (primarily – blood, serum, plasma, tissue extracts, or urine).

Bioanalysis involves two key steps – preparation of sample to be subjected for analysis and detection of the final compound. For sample preparation, liquid-liquid extraction, protein precipitation, and solid-phase extraction are routinely employed. Furthermore, the compound is detected using sophisticated analytical techniques. High-Performance Liquid Chromatography (HPLC), Electrospray Ionization (ESI), Atmospheric Pressure Chemical Ionization (APCI) are a few examples of the routinely employed techniques.

Bioanalytical overview for the drug discovery and development –

Bioanalytical framework for the discovery of the drug and its commercial production involves the following six stages –

Discovery – 

At the discovery stage, the product screening leads to microsomal stability, screening liability for the preliminary in vitro cytochrome P450 inhibition, and detection of CaCo2 permeability.

Pre-clinical stage 1 – 

At this stage, the drug product under analysis is subjected to the characterization of PK disposition in animal models such as rodents or dogs or monkeys. This is generally carried out in the form of a single dose study or multiple-dose study or absolute bioavailability. Additionally, the pre-clinical stage 1 trials also reveal information about the following –

  • PK disposition based on the route of drug administration.
  • Screening of the drug product for toxicology testing.
  • Detection of the liability of the definitive in vitro drug-drug interactions.
  • Potentials of in vivo drug-drug interactions.
  • Detection of the drug exposure levels in toxicology species.
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Pre-clinical stage 2 – 

This stage deals with the characterization of the parent compound and other metabolites present within the toxicological and pharmacological species. It also helps the biolab to generate characterization data for in vivo drug-drug interaction studies.

Clinical Stage 1 – 

At this stage, the bioanalyst obtains drug characterization data for PK disposition in healthy human subjects. This is monitored through a single dose administration, multiple-dose administration, and bioavailability assessment. If needed, the trials are extended to the special population (geriatric, pediatric, hepatic dysfunction, and renal impairment).

Clinical Stage 2 – 

This study is performed for drug characterization to obtain the value of PK disposition of both the parent compound and its metabolites in serum, plasma, and urine.

Clinical Stage 3 – 

The final stage in the clinical trial of a drug product is the evaluation of the potential of the possible drug-drug interaction with other agents commonly prescribed for the targeted subjects.