The UK has a long history of drug discovery and innovation. From the early days of drug development, when Alexander Fleming discovered penicillin, to the development of the COVID-19 vaccine, the UK drug development industry has continued to have a great impact on the development of medicines treating patients worldwide. The cornerstone of this is safe and effective development, embodied within a robust regulatory framework.
In drug development, every new treatment starts its journey with preclinical studies. This crucial first phase is not only a prerequisite in terms of regulatory requirements but also the first strong foundation block for medical breakthroughs, ensuring that the drugs are safe and exert no harm. In this article, we examine preclinical analysis as a whole and explain why it is pivotal within biotechnology and pharmaceutical landscapes.
What is preclinical analysis?
This refers to the evaluation and battery of studies that any new pharmaceutical compound needs to undergo before it can be considered safe for human trials. Various tests are conducted in the preclinical analysis stage, which can be in vitro (within a culture, dish, or test tube) or in vivo (on living organism models). Professionals, such as those at Alderley Analytical, carry out the full range of preclinical bioanalytical testing.
Preclinical analysis aims to determine whether a compound is safe, assess its absorption, distribution, metabolism and excretion and to assist in predictive dose estimates for future clinical trials This type of testing is also vital to investigate any possible toxic effects a compound could have and how it may behave in human trials.
The importance of preclinical bioanalysis
As mentioned, this part of the process of drug development is vital. It is the first line of defence against unwanted impacts of developed drugs on humans, and without it, human trials would present an unacceptable level of risk. By employing rigorous tests in a lab, any products that do not meet safety standards or show potential adverse effects, such as a high level of toxicity or potential carcinogenicity, can be either shelved completely or adapted to remove the risks present.
Only products that meet these rigorous safety standards can move on to the next step in the drug development process.
What types of preclinical studies are there?
Each type of preclinical study has a key purpose in drug development. Some examples include:
- ADME – Absorption, Distribution, Metabolism and Excretion
- DRF – Dose Range Finding – estimates of safe dose levels
- Toxicology – studies evaluate whether there could be potential harmful effects at different levels of exposure.
- Immunotoxicology – specific studies to ensure no harm occurs to the immune system
- Safety Pharmacology – to identify pharmacological effects that are undesirable and produce adverse effects.
These preclinical investigations encompass the study of
Toxicokinetics/Pharmacokinetics– how a drug is, absorbed, metabolised, distributed, and excreted, and
Pharmacodynamics assess the drug’s impact on the body as a whole, looking at the physiological and biochemical Interactions. These factors are achieved by pivotal bioanalytical testing.
Regulatory requirements
Preclinical data is vital for drug development as it informs the critical decisions and strategies for developing a compound to the point where it meets the criteria for human trials. In the UK, this stage is very tightly regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA requires the submission of a comprehensive body of evidence of preclinical data before it approves clinical trials on human beings.
This framework ensures that substantiated preliminary research is robust and that only compounds that pass this stage are used in further therapeutic development.
To sum up, preclinical analysis provides a vital phase in drug safety and compound disposition. Ultimately, it reduces the risks of harm to humans from the first clinical trial onwards during drug development.