The Different Stages of the Drug Development Process

The drug development process is by no means easy, as it entails a complicated process, which includes three major areas—drug discovery and product development, pre-clinical research and clinical trials.

Drug Discovery

Simply put, it is the process by which drugs are discovered and/or designed. It is a big facet of the fields of biotechnology, medicine and pharmacology and quite understandably so. In order to ascertain the suitability of a compound, it is subjected to a few steps: identification of candidates, synthesis, characterization, screening and assays for therapeutic efficacy. Developments in research and advancements in technology notwithstanding, this stage of drug development is still by far, the longest and most expensive. The information required to even get this stage started requires a lot of time, effort and money.

Pre-Clinical Research

Pre-clinical studies are completed before human testing and are mainly done to determine a drug’s safety profile. This stage primes the drug for human testing, getting concerns such as toxicity and extreme adverse reactions out of the way. Pre-clinical tests are usually administered on microorganisms or animals in conditions that simulate normal human settings.

Clinical Trials

Clinical trials are conducted on human test subjects to collect important safety and efficacy data. Depending on the drug, its proponents and its nature, either volunteers or patients are enrolled into the study. In order to ascertain the safety of the subjects, a study must get the necessary health committee or ethics committee approvals prior to commencement.

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UPM Pharmaceuticals provides pharmaceutical development support. It aids pharmaceutical companies each step of the drug development process. They have experience working on product development projects with multi-million dollar companies. Learn more at http://www.upm-inc.com or call 410-843-3700.