The Probability of Drug Development Success

By August 29, 2022 Pharmaceutical Development
The Probability of Technical Drug Development Success

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New drug discovery is vital for treating existing illnesses and preventing the emergence of new ones in the human population. As technology advances, drug development is expanding, with cutting-edge technologies increasing to monitor and discover processes which contribute to the success rate of new medications.

Other, more effective drug testing methods are also evolving, such as substituting non-animal tests for animal tests (for example, zebrafish research).

Stages of the Drug Development Process

Before a medicine can be registered and sold on the pharmaceutical market, it must undergo 4 primary testing phases. For a medicine to advance from Stage I to final FDA approval, its safety and efficacy must be shown over a minimum of 10 years.

Stage I – Research and Development

This phase begins with testing hundreds of substances for safety, efficacy, dose, interaction, adverse effects and many other criteria. Various chemicals are removed progressively, leaving just those to be examined in the subsequent phase.

Stage II – Preclinical Research

Before a medicine can be administered to people, it must undergo preclinical testing. At this stage, in vivo or in vitro testing on animals (or clinical laboratory models established for this purpose) are often utilized. Levels of toxicity and dosage have a key role in this phase.

Stage III – Clinical Research

This occurs when the preclinical stage determines that a medicine is safe for human testing. The FDA (Food and Drug Administration) establishes testing requirements for safety concerns. According to specific criteria, groups of individuals are picked (length of the trial, dosage, how the drug will be administered, when reviews will be carried out). These groups enter sequential Clinical Phases (I, II and III). After the trial, the results are examined to decide whether or not to proceed to the next stage.

Stage IV – FDA Review

Once a medicine has completed the clinical research stage and has been deemed safe for human use, it must be submitted to the FDA for evaluation and clearance. The FDA may seek further research or approve the medicine, a process that could take up to one year. Additionally, the medicine developer must provide specific data, such as labeling information, patient information and use instructions.

After FDA registration, a new medicine can be marketed.

Rates of Drug Development Success

During the drug development process, a medicine may be transferred from one phase to the next or abandoned owing to toxicity, inadequate effectiveness or prohibitive cost. This probability is known as the “success likelihood”.

The U.S. Food & Drug Administration provided data about the likelihood of success, advancement to the subsequent stage, and duration of drug discovery.

  • Stage I (several months): 70% 
  • Stage II (few months to 2 years): 33%
  • Stage III (1-4 years): 25% to 30%
  • Stage IV: 90.6%

In Stage II (preclinical) research, numerous chemicals and variables are evaluated and deemed unfeasible, resulting in a smaller number. This is an experimental phase, and it may be decided not to go to the clinical research phase owing to costs or other negative results.

What Causes Failed Drug Development?

What Causes Failed Drug DevelopmentA drug’s development may be discontinued for a variety of reasons. This is referred to as a “clinical failure” and does not necessarily indicate that the medicine has “failed,” but rather that it is unsuitable for its intended purpose. Failure in drug discovery may occur due to:

  • A lack of reaction to the medicine
  • Lack of effectiveness toward the illness under study
  • Danger exceeding the reward
  • Security concerns
  • Lack of capacity to calculate the appropriate dosage
  • Cost

There may not be sufficient information or data available to examine a rare condition, which may contribute to clinical failure. Due to a scarcity of past research, it is more challenging to create drugs for certain rare conditions. Regulatory bodies may grant these medications “orphan drug” designation to stimulate research in these areas by providing a fast-track proposal.

Comparatively, studies in specific domains (such as oncology) are more feasible than research on diseases which impact a tiny fraction of the population.

The success of drug discovery is contingent on a number of elements, including careful planning, the potential usefulness of the product in treating and preventing illness, the amount of money spent, and the field of study.

To learn more about drug development success, visit online or call us at (315) 469-2800 today.

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