The toxicity of substances contained as impurities in medicines is of paramount interest to consumers, who demand assurances that products do not harm their health or well-being. The cost of ignoring this fact is enormous for companies: in addition to the direct impact on people, errors damage the integrity of the brand and the company's position in the market.
Since the past decade, as a result of scientific advances and for ethical and practical reasons, (Q)SAR studies have been increasingly introduced in toxicological evaluation, with the aim of reducing the number of animals used in each test and refining existing procedures to reduce animal stress and suffering.
Animal models constitute the experimental unit in in vivo toxicological studies , and their use is governed by regulations with a view to an adequate use, according to the requirements of the study and taking into account ethical principles.
The selection of the different toxicological evaluation methods to be used, species, time, money and route of exposure, as well as the dose levels to be used in them, depend on the characteristics of the substance to be tested, as well as on the objectives of its possible use in humans.
One of the limitations of evaluating degradation compounds generated in some drugs is the limited amount of sample available, in addition to the fact that the process of purifying the compound in question in sufficient quantities to be able to carry out the relevant toxicological studies to achieve an adequate risk analysis is extremely expensive and sometimes unfeasible.
With Q(SAR) studies, the toxicity of degradation compounds is evaluated based only on the knowledge of the chemical structure of the compound to be studied, alleviating the problem of having to have the pure substance to perform the aforementioned experiments, making them a viable and reliable alternative that saves time and money, in addition to providing information quickly, avoiding the reformulation of pharmaceutical products.
The harmonic evaluation of the results of these studies allows us to reach a more integral criterion of the toxicity of the substance evaluated and its possible consequences for humans, other living species and the environment in general.
In order to ensure the proper conduct and interpretation of toxicological studies and to harmonize sanitary registration requirements internationally, ICH guidelines have been developed (Q3 A and B in addition to Q6), where criteria have been defined to establish the toxicological basis for qualifying degradation compounds in impurities and therefore modifying specification limits based on the evidence provided by years of research in the field of toxicology.
By using in silico tools, it is possible to calculate different endpoints of toxicological and ecotoxicological interest such as:
- Mutagenicity
- LD50
- LOAL/LOEL/NOEL/NOAEL
- Irritability
- Skin corrosion
- DT50
- Bioaccumulation
- Biodegradation
- Aquatic Toxicity
- Etc.
In QSAR Analytics we have a team of experts, certified by the OECD; likewise, we work with the OECD 69, ICH Q3A and B, ICH M7 and ICH Q6 guides, among others, ensuring that the evaluations performed have a high degree of certainty, in addition we have developed a process that adds value to each of our business partners with whom we have achieved that they have reliable information that allows them to modify their specification limits and thus achieve the registration of their products. To date, our guarantee continues to be our perfect record in getting customers to achieve their registrations.
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