Before submitting an IND application, the concerned drug must go through a comprehensive series of in-vitro and in-vivo toxicity testing to ensure maximum safety in clinical trials. Considering the ethical issues and the cost of in-vivo animal tests, the pharmaceutical industry now relies more on in-vitro methods for toxicity testing in the drug development phase.
Here, we answer the common questions regarding the in-vitro toxicity testing in drug development.
What is the right time to scree
Good Laboratory Practice (GLP) is a set of standards for conducting toxicology studies. They define how these studies must be planned, performed, monitored, recorded, reported, and stored for future reference. However, not all toxicology studies require compliance with the GLP standards. Basic screening tests where the safety of the product is not assessed do not require GLP compliance. Non-GLP never indicates complete ignorance of the GLP standards, it’s only that few standards may not apply
The number of animals used in toxicology studies is continuously increasing. Every year millions of experimental animals are sacrificed in the name of scientific research. Scientists across the world discuss about the pain, distress and death experienced by the animals during scientific experiments.
To save the decreasing number of animals on this earth, many alternatives to animal testing are proposed. However, much needs to be done in this aspect and save animals from the clutches of scien
Nowadays, the state governments lay more stress on prescription monitoring programs (PMPs). In such a scenario, the healthcare facilities have to test and prevent the abuse of commonly prescribed medicines.
However, they have one major dilemma. Whether to work with a drug confirmation or a toxicity testing labs?
Here, we tell you the difference between the two lab services and what each of them accomplishes.
A drug confirmation lab only verifies the drug usage
The facilities of this lab
Toxicity testing of pharmaceutical drugs forms a critical part of the risk-benefit assessment that balances the beneficial effects of the drug against the observed toxic and adverse effects. Despite advances in toxicity assessment, many drugs and chemicals are marketed without adequate toxicology data.
The increasing demand for nonclinical safety data in the early phase of drug development has posed the following challenges to toxicology testing, which must be adequately addressed:
Microsampling or the use of small amounts of sample tissue has become one of the hot topics for discussion in animal research. Many researchers are now discussing, investigating, and utilising the benefits of microsampling in toxicity testing.
Though there's a long way to go before microsampling becomes a routine in animal research, it still offers three benefits for toxicity testing:
1.It supports the 3Rs strategy
Due to the ethics related to the use of experimental animals, researchers ha
Majority confound toxicity testing with the procedure of knowing the toxic effects of a drug on experimental animals and determine their safety for human use. No doubt, toxicity testing is of paramount importance to screen any new drug before it can be used safely in humans.
But, is the importance of toxicity testing only limited to the drug safety profile?
Let’s have a look at other important benefits of toxicity testing:
Establishment of a dose response curve th
Nearly 15 million animals are used across the world each year for testing medications and newly developed drugs. The National Centre for Laboratory Animal Sciences in Hyderabad supplies nearly 50,000 animals to various laboratories in India.
Why are so many animals sacrificed at the hands of scientific researchers? What do these researchers look for during animal testing of drugs and chemicals?
These experimental animals are used to test the safety and efficacy of newly developed drugs or