The FDA has some very specific rules about Good Lab Practices. These rules adhere to all and every kind of research that takes place in drug interaction studies. Drug interaction is a very crucial part of drug development that tests the toxicity of drugs and sets the ground rules for dosage.
Any TK study would require good lab practices that adhere to these rules set in place by the FDA. This is sectioned under the OECD guideline which has been recognized as standard procedure around the world.
These practices come with various challenges. Especially in the case of TK study, analysis requires strict adherence to the structure of the tests including the variables. Labs must comply with this regimentation to ensure the accuracy of TK analysis.
These challenges include:
In most cases, for labs to be compliant with FDA issued guidelines several inspection programs are carried out. This certifies the lab to operate under provided guidelines. In reality, many labs and CROs skip this step and kick-start their studies. This has many times led to non-compliance issues and delivery of reliable but invalid results and analyses.
GLP toxicology studies fda, in particular, require quality assurance. This is determined by the practices that the lab puts in place to ensure that test results are accurate and precise. This form of quality assurance is a daily challenge especially in the United States due to several labs that do not comply with FDA guidelines, even after claiming the same.
One of the most important aspects of the TK study is the use of animal specimens. Most of the steps that involve checks on dosage, response to dosage et cetera require careful vigilance. Without proper animal facilities, it is next to impossible to ensure precise results.
Drug interactions are very specific and TK analysis is a particular aspect that relies on animal subjects. There are several pre-decided conditions to which these animals are subjected to ensure accurate results. Without GLP in place, it could lead to disastrous results when it comes to animal facilities.
Laboratory equipment areas
A well-equipped lab is a dream zone for all aspiring companies looking forward to getting their next drug tested. While complying with the set guidelines requires precision, it is also necessary to ensure that proper laboratory equipment is available.
For GLP toxicology studies fda ensure that there are Triple Quadrupole Mass Spectrometer, Ultracentrifuge, drug screeners, immunoassay analyzers present in the lab. These are some of the most commonly used devices for TK analysis of drug interaction.
Apart from all such challenges, there are a host of other issues like management, training, standard operating procedures that most labs do not follow. This is overlooked in many cases for makeup based products, but drug testing is a completely different aspect that must comply with the set OECD standards.
While choosing a laboratory or a CRO as a whole, make sure that all of the necessities for the tests are met and complied with the good lab practice guidelines besides the standards of drug testing.