According to information provided in the Congressional Budget Office’s 2006 study, Research and Development in the Pharmaceutical Industry, it costs pharmaceutical companies an average of 12 years and $800 million dollars to create and bring to market a drug that is based on a new molecular entity (NME). In sharp contrast, drugs that are based on modifications of existing medicines average just 25% of the cost of an NME to develop.
While somewhat cheaper to bring to the market, non-NMEs are still quite time-consuming to develop, as they usually require extended clinical trials to prove that they are safe from a toxicology standpoint. Trials are also needed in order to prove that the new formulations remain capable of producing consistent and repeatable results over time.
Rigorous Testing and Reproducible Results: the Cornerstone of R&D
Long before a potential new medicine makes it to the clinical trial stage of development, the chemicals and other compounds that are used in the creation of the drug must undergo rigorously, and repeated, testing.
Molecules likely to have the desired properties that have been targeted for research must first be identified and isolated. Sample analysis must be performed to determine potential toxicology. The likely efficacy of the potential medicine must also be determined prior to scale up and producing the compound in its dosage form.
High Purity Solvents Critical to Identify and Test Molecules with Potentially Beneficial Properties
At each stage of drug research and development, high purity solvents such as those produced by RightPath Industries should be used in order to produce cost-effective, and reproducible results on a consistent basis.
Residual solvents and other impurities must be able to be reliably measured, controlled, and accounted for throughout analysis. When they are not, the remaining solvents and impurities may skew test results and sabotage drug studies.
Impurities and other contaminants have additional adverse effects on sample analysis. Impurities in the sample can make it impossible to calculate the amount of the active pharmaceutical ingredient (API) in the sample. Impurities make it difficult, if not impossible, to determine the relative safety and level of toxicity in the sample.
Mistakes made during the testing phase are often costly and can threaten the feasibility of the entire project. In order to control some of the costs associated with the development of a new drug, research labs must make every effort to ensure that each phase of testing is conducted in the most stringent and controlled manner as possible.
By only using solvents of a high purity, researchers are able to accurately separate polar molecules during the beginning stages of drug discovery. They can then reliably exclude non-polar impurities from bio-molecules in sample testing.
This reduces variability in the sample itself and increases confidence in the results of the sample analysis. Once reliable and consistent results are received, it clears the way for additional research and development to move forward.
Modern Medical Advances and Breakthroughs Impossible Without Reliable Sample Analysis Methods
Of course, being able to isolate and identify potentially beneficial molecules is only one critical step in the drug development process. Once a lead compound has been identified through testing, and the potential toxicology on major organs in the body determined, additional steps are generally required before clinical trials on humans can begin.
Some of the additional steps that are necessary at this pre-clinical stage include determining the compound’s specific chemistry, as well as defining its level of stability and solubility. Throughout each of these steps, reliable sample analysis remains a primary investigative tool.
At each stage, the development of therapeutic medicines becomes impossible without accurate test methods and procedures that produce reliable results on a cost-effective basis.