As we’ve said before, the drug development process is long and complex. There is always a measure of anticipation from the market and patients, but there is also an overwhelming amount of work involved. Ultimately the lengthy processes and protocols are there for two important reasons: to ensure safety and effectively demonstrate the drugs effectiveness and efficiency (efficacy).
The first stage can be referred to as the initial development. This is where potential drugs start life. Research begins as a response to need, an idea, grants and requests from governments and foundations, or all of the above.
Next comes the pre-clinical development stage. This is where researchers assess toxicity and examine the effects of the drug. There are also initial Pharmacokinetic (PK) and Pharmacodynamic (PD) studies.
PK studies involve discovering what the body does to a drug. How does the body absorb, distribute, metabolise (transform) or eliminate the drug? While PD studies concentrate on what the drug does to the body. How does the drug react with naturally occurring chemicals and substances? What is it’s mechanism of action?
Having shown promise in the first two stages, a drug can potentially advance through to clinical development. We say ‘potentially’ because clinical trials require significant funding, rigour and a drug with adequate scope and its own potential to become a successful and effective response to a medical need.
As per our earlier post, only 250 drugs from every 10,000 discovered or researched will even get to this stage, and only five will progress to the next. The length of time spent on initial and pre-clinical development varies greatly, but on average takes a minimum of three years.
In our next post, we’ll discuss the structure and process necessary for undertaking clinical trials that adhere to the standards set by regulatory bodies, and give drugs their best chance for progression.
We’ve also opened a discussion in the forums about pharmaceutical development; please feel free to post any comments, questions or insights here.
