The Importance of Animal Research and Testing in the Pharmaceutical Industry
Animal testing of certain drugs, methods or means is regulated by law. This is especially important in pharmaceutics, when it is necessary to comprehensively study a new drug in order to understand how it suits people, what can be expected in general when taking it, what side effects may occur. That is why in pharmaceuticals, preliminary animal testing of all drugs is a prerequisite. We interviewed John Carry, an expert in preclinical studies of a leading pharmaceutical company thecanadianhealthcaremall.com, about what animals are used in research activities, how the tested drugs can affect their health and more.
What is Animal Research?
Animal research includes interventions or treatments for experimental purposes that can involve pain, suffering or harm for an animal.
The selection of animals for research is based on the similarity of the species of animal and human in respect of such aspects as:
- pharmacodynamics (pharmacological safety);
- physiology and pathophysiology.
Pharmacodynamics (the effect of drugs on the body) in animals should be comparable to pharmacodynamics in the human body. It is necessary to take into account the target, structural homology (common origin), distribution, methods of cellular communication, and the effect of the drug.
In order to calculate initial doses for initial clinical trials and predict therapeutic doses for subsequent trials, preclinical studies collect information on the pharmacokinetics (how the body reacts to the drug) of the test substance, and the calculations are based on the results of toxicological studies. In the case of biologics, calculations are often based on the body’s response to the drug.
When selecting animals for research, it is important to compare the physiological and pathophysiological characteristics of the animal species to be used with those of the human organism. In the past, healthy animals were used to predict the efficacy and safety of a drug in patients who already had changes in physiology due to the presence of the disease. Now, preclinical studies are more often carried out on animals with the disease under study. When extrapolating data to special patient groups, such as pediatric and geriatric patients or pregnant women, special parameters must be observed.
The choice of animals is also driven by practical considerations, such as the availability of the animal species and the ease of use under standard laboratory conditions and procedures. When choosing animals, screening tests are often used.
What is Animal Testing?
Approximately 65% of experimental animals are used to obtain applied biomedical knowledge, in particular pharmaceutical. They help clarify:
- normal and pathological course of various processes in the body;
- the degree of toxicity of the substance;
- potential harm/danger of developed medicines.
Approximately 1% of laboratory animals become teaching aids for future doctors or biologists. The rest are needed to obtain fundamental knowledge.
Examples of test animals:
- rats (osteoporosis, inflammatory diseases, diabetes, obesity, cardiovascular disorders, neurodegenerative diseases, oncology);
- monkeys (osteoporosis, inflammatory diseases);
- pigs (cardiovascular disorders such as hypertension);
- mice (oncology, some genetic diseases).
Drug discovery and animal research labs can benefit from LIMS software.
What Does LIMS Stand For?
The Laboratory Animal Science Buyers Guide is the database dedicated to laboratory animal researchers, helping them find the products & services they need. Research is based on making and recording observations. The purpose of LIMS is to obtain reliable information based on test results and optimize the management of this information in order to use it to make correct timely management decisions.
What Are the Benefits of Using Animals in Research?
Such animal studies allow to expand knowledge about the drug. In order to make changes to the instructions for the use of the drug and, for example, to expand the indications for use for children, additional studies are required, including preclinical studies in animals.
Therefore, animal testing is an essential part of the drug life cycle. In the pre-registration period, their conduct provides the necessary data to predict the effect of the substance under study on the human body and secure the first use in people. Animal studies provide an opportunity to confirm the high quality of the drug and its absolute safety.
How Does the Drug Development Process Work?
The drug must hit the target exactly, like a guided missile. It is determined by biologists: they find out the cause of the disease and identify the target at the cellular level.
What should be the “weapon”? Chemists decide how and with what to “hit the target”: they synthesize various compounds.
The search and synthesis of new molecules is ongoing; the most successful substances are being finalized by biologists, pharmacologists, medical chemists. Then preclinical studies begin. Their purpose is to test the drug for toxicity and carcinogenicity and answer a number of important questions: what diseases does the drug treat? Is it safe? And what happens to the drug in the body?
The third most important stage is clinical research. They include several phases: testing a drug on animals and then on healthy volunteers, then proving efficacy and safety in patients with a specific disease. The next phase is testing the medication on large groups of patients of different ages, with various comorbidities. And the final phase is registration: identifying the differences between a new drug and analogues, identifying and determining previously unknown or incorrectly identified side effects.
On average, it takes 14 years for each new drug to travel from the lab to the pharmacy display case. This process costs about $2 billion.