This is Part 2 of a 3-Part series detailing a product’s pathway from research & development (R&D) to clinical trials to manufacturing.
Of the thousands of promising drugs that enter the R&D phase of pharmaceutical drug development, only a small fraction move forward into clinical trials. And 7 out of 8 drugs that do make it to clinical testing will never reach the marketing phase. (1) The current state of pharmaceutical testing is clearly bleak; researchers and corporations should therefore be informed about each part of the process to increase their likelihood of success. Following are descriptions of each clinical phase and information on how a drug can progress into FDA approval.
IND Application
Before researchers can embark on human drug testing via clinical trials, an Investigational New Drug (IND) application must be filed with the FDA. The FDA requires certain information to be contained within the application; these include 1) pre-clinical study results, 2) manufacturing information, 3) clinical protocols, and 4) investigator information. (2)
Phase I
Upon approval of its IND application, a drug enters Phase I of clinical development. The overarching purpose of Phase I is to assess a drug’s safety as it is administered to humans for the first time. During this time, researchers study measures such as dosage limits, mechanism of absorption, and overall body response; a small human sample size (anywhere from 10-20 people) is typically used in case of adverse side effects. (3)
Phase II
Successful completion of Phase I indicates that a safe drug dose has been identified and it is now ready for effectiveness testing. Using either a single dose or varying doses across treatment groups, researchers administer the drug to a larger group of people (anywhere from 20-40 people). Individuals with diseases that aren’t responding to other forms of treatment often volunteer for Phase II clinical trials in hopes that the experimental drug will effectively treat their condition; experimental cancer drugs are a common example of such practices. (4)
Phase III
An experimental drug is greenlighted into Phase III after it has demonstrated safety and effectiveness in Phases I and II. The purpose of Phase III is to confirm these criteria in larger groups of people; principal investigators may enroll hundreds to thousands of people for a Phase III clinical trial. Most drugs that enter this phase are intended for disease treatment, and may be administered alongside an already existing standard treatment to determine if the new drug is more effective. Phase III may last for years, and upon completion the pharmaceutical company can submit a request to the FDA for its approval. (5)
As you press forward with a potentially promising drug therapy, keep in mind that very few drugs actually make it to the clinical trial stage of drug development. To optimize your drug’s chances of success, it is imperative that your R&D phase yields a high quality drug, which can only be produced with high quality equipment.
At BEEI International, we produces homogenizers that can yield a variety of relevant products, such as emulsions, suspensions, dispersions and lipids. Importantly, these products go on to make up the injectables, inhalants, anesthetics, vaccinations, and more that are used in the clinical trials described here. In addition, we have extensive experience assisting our product users as they transition through the drug development process.
Visit us here to learn more about how their homogenizers can optimize your drug’s chances of success.
Check out Part I of the drug development series for more on the R&D process; and stay tuned for Part III on drug product manufacturing, the final installation of our drug development series!
