'All substances are poisons; there is none which is not a poison. The right dose differentiates a poison'- Paracelsus
Anciently toxicology was known as the ‘Science of Poison,’ now a days it is defined as the study of the effect of chemicals on living organisms and their evaluation as whether these entities are harmful or not or estimating a safe range. For the establishment of safety margins from the adverse effects of chemicals, toxicology depends on a few factors like dosage, route of exposure, dosing regimen, fate of the chemical and their biotransformation. The safety level of chemical is picked by the execution of sets of step wise experiments. Toxicology plays a major part in the drug development process to determine the safe dose and drug response on an exposed organism. It includes four disciplines like biology, chemistry, pharmacology and lastly medicine with an intervention of information technology up to some extent.
In the current scenario toxicology studies are of vast importance in the field of Pharmaceuticals, Agrochemicals, Nutraceuticals and Ayurvedic Products.
Pharmaceutical Toxicology: Most important concern in the pharmaceutical industries are the side effects of their drug or medicine. It is one of the greatest causes of failure in the drug development process. Toxicologists conduct safety studies in accordance with the regulatory guidelines (ICH, OECD) to show regulators that a certain drug is safe to use for its intended indication. The pharmaceutical industry initially conducts efficacy studies before entering safety screening phase of their molecule or biomolecule. This process of screening of a potent test compound is recognized as part of early drug development which was initiated from drug discovery as below:
Agrochemicals: As the name suggests chemicals used in agriculture commonly include pesticides (insecticides, herbicides, fungicides, nematicides), synthetic fertilizers, natural (manure), hormones, growth enhancers. Over a period, when used for a long time these agrochemicals become pollutants to our ecosystem. Establishment of their safety and risk assessment is equally important as any pharmaceutical drug. In the case of agrochemicals, it is known as ecological risk assessment (ERA). It works first for the protection of ecosystem and second registration of agrochemicals or regulatory purposes (CIBRC).
Ayurvedic Products: In India, general guidelines for safety/toxicity evaluation of ayurvedic formulations issued by Central Council for Research in Ayurvedic Sciences (CCRS), Ministry of AYUSH, Govt, of India, New Delhi for drug development in the field of ayurveda popular as ‘AYUSH’ (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy).
To conclude, toxicity is an inevitable part of drug development without safety assessment no molecule or drug will step up from pre-clinical to clinical level of therapeutic expansions. We, at Dabur Research Foundation (DRF), have the expertise to undertake the toxicity studies for Pharmaceuticals, Nutraceuticals, Agrochemicals, and Traditional Medicine fields for regulatory submissions.