Bioanalysis is a crucial part of a drug development process. Bioanalysis and bioanalytical methods have evolved considerably over the past few years in terms of regulations and technological platforms.
Bioaalysis is basically the quantitative measurement of the metabolites of drugs found in biological fluids such as plasma, blood, urine, serum, or tissue extracts. It forms an integral part of the drug development process in the early stages as this data forms the basis of further studies. It aids the drug development programs on the pharmacokinetics and metabolic fate of chemicals present in living cells and animals.
Use of Bioanalysis is vital right from the preclinical stage through to the clinical drug development to post-marketing support as well. It can also extend to clinical therapeutic drug monitoring. Reliable data derived from sensitive, selective, and reproducible analysis of biotics and xenobiotics in biological samples is an integral part of each and every successful drug discovery program.
Bioanalytics incorporate some sophisticated techniques such as linking of sample preparation and advanced separations. This is done with the aid of MS and NMR detection systems, robotics, and automation. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality.
The use of such cutting edge technologies leaves barely any room for errors.
As in the case of any scientific endeavors, the drug development process is also largely dependent on the accurate quantification of the different elements. Bioanalysis is hence very important in the pharmaceutical industry as it focuses on providing these proper quantitative measures of the presence of active drug or/and metabolites.
Apart from the pharmaceutical companies, Bioanalysis also sees application in other areas such as in the case of drugs for illicit purposes, anti-doping tests in sports, forensic investigations as well as environmental concerns.
Initially, the application of bioanalysis was only in terms of the measurement of small molecule drugs. But over the past two decades, there has been a steady rise in the development of biopharmaceuticals such as proteins and peptides, for instance. These have been developed to fight the same diseases like small molecules. Bioanalysis plays a vital role in such cases as well.
Bioanalysis also aims to show the reliability of the method developed for the quantitative measurement of drugs or metabolites. As per the guidelines by the regulating bodies, there are a few fundamental parameters that are carefully evaluated during Bioanalysis. These parameters help optimize the existing methods to increase the overall efficiency in the process, identification of liabilities, and prioritization of risk issues.
Benefits of adhering to these parameters
- Reduces sample volumes
- Reduces analysis cost
- Reduces environmental impact
- Improve sensitivity
- Data quality
- Data handling and processing
For different types of drug approval processes, the bioanalytical method validation and development data are required by the sponsors. Bioanalysis services help companies walk through the scientific as well as regulatory challenges that are faced in this dynamic and ever-evolving industry. Bioanalysis forms an essential part of drug development is it assists safe and efficient drug development with lesser time schedules and costs.