The history of science shows a clear tendency of ever-growing expectations and higher standards. The scientific community takes pride in the solid foundations of the scientific method, putting more and more pressure on quality data and consistent methodologies. Over the last century, these ideas became the basis for Good Laboratory Practice (GLP) and the 3Rs.
How research is conducted and the individual components of a test or assay are just as important as the internal logic of a hypothesis or proof.
GLP and the 3Rs are sets of guidelines meant to ensure biomedical research meets a higher standard. The inherent value of finding a consensus on methodology and experimental controls is immediately obvious to anyone attempting to understand new research or reproduce its results.
What is Good Laboratory Practice?
For biomedical research and other laboratory science, GLP is an integral aspect of quality data. The set of guidelines started as a smaller initiative in the 1970s in New Zealand, but grew into an international standard as scientists around the world saw the benefits of ensuring proper methodology and controls.
GLP focuses on the results, looking into how data is derived and whether or not an experiment holds merit. The guidelines ensure a solid structure for biomedical science, leading to higher quality data that is accurate and reproducible.
GLP is a carefully designed set of guidelines used to produce data that any laboratory can recreate.
In practice, GLP translates into proper documentation for every step and every sample used in a test of assay. Ensuring and enforcing a scientific core for preclinical trials and other biomedical research naturally leads to higher quality and more useful data in drug discovery.
What Are the 3Rs?
As a slight contrast to GLP and its focus on the quality of the data derived from tests and assays, the 3Rs are a set of guidelines meant to ensure the well-being of living organisms used in preclinical trials and other biomedical research.
These guiding principles were first described in the mid 20th century, quickly becoming an industry standard for pharmaceutical research and the ethical treatment of animal models in biomedical science.
As the name implies, each of the 3 “R”s works towards the better treatment of animal models:
- Replacement: Perform tests and assays without animal models.
- Reduction: Increase effective productivity for more data with fewer animal models.
- Refinement: Innovate techniques and technology for better treatment of animal models.
The safety, toxicity, and efficacy of a new drug needs to be well researched before a new treatment can move to clinical trials.
The 3Rs are designed to work with the needs of the scientific community while also ensuring the well-being of animal models. In practice, the 3Rs can also lead to innovative experiments and better data for clinical trials and future human patients.
GLP and the 3Rs Work Well Together
Good Laboratory Practice and the 3Rs are similar but separate guidelines important for anyone involved with biomedical science and pharmaceutical research. GLP by itself does not focus on safety requirements or the ethical treatment of animal models and the 3Rs are seemingly more concerned with the treatment of animal models than the data itself.
- GLP: Quality data and proper use of the scientific method.
- 3Rs: Ethical treatment and well-being of animal models.
In many countries both GLP and the 3Rs have been drafted into law making it necessary to understand how they work together. Even though the two guidelines are focused on different areas integral to biomedical research, they work well together towards the common goal of better more verifiable research.
Following the 3Rs and ensuring animal welfare directly translates into better quality data that follows GLP. There are many examples of how improperly caring for living models produces skewed results and incorrect data.
If the animal models and their biological system are not behaving normally, the data derived from any tests and assays may not be accurate or applicable to humans.
Zebrafish Benefits for GLP and the 3Rs
- Fully developed in less than a week.
- Generations with hundreds of offspring.
- Transparent embryos adapted to non-invasive in-vivo experiments.
- Vertebrate model naturally evolved for smaller spaces.
- Proven track record in biomedical research.
As a concrete example of how GLP and the 3Rs can work well together, zebrafish are an alternative animal model well adapted to meeting both guidelines. The small fish are easy to care for, share over 80% of human disease gene DNA, and their natural behavior is well suited to the fast pace of early drug discovery.