Stages of Drug Development

Stages of Drug Development

Drug development is a multi-stage process that strives to bring new drugs to patients. Each of the stages involved can be very time-consuming - that's why it takes roughly 10-15 years to complete the process and make a new drug ready for use in the patients.

In the past few decades, the process of drug development has become more complex. It involves preclinical testing, clinical testing, an investigational new drug (IND) application, new drug application (NDs), and post-marketing surveillance. After a comprehensive medical review, the main goal of drug development is to offer more effective and safer treatments to patients.

Discovery and Development

The process of drug discovery is the initial step in drug development. The discovery process includes the identification of active chemicals and assessment of their activity and safety through various techniques. The active chemicals can be altered to give them more drug-like qualities through a process called medicinal chemistry. After the identification, optimization, and validation of an active compound, it is pharmacologically tested to determine its therapeutic effects and safety.

Preclinical Testing

Preclinical testing is a stage in the drug development process that determines drug safety and efficacy in cells and animals in order to predict its effects in humans. The relevant governing bodies must also approve any preclinical experiments that are carried out in animals. The governing bodies must ensure that studies are carried out safely and ethically, and only those drugs that have been proven to be safe and effective will be approved.

The International Conference on Harmonization (ICH) has created guidelines for acceptable preclinical drug development technical requirements. There are two ways by which preclinical trials can be conducted, including general pharmacology and toxicology. In addition, pharmacokinetics (how a drug is metabolized and cleared) and pharmacodynamics (what effects a drug has on a body and the mechanism by which those effects are mediated) are also assessed.

Clinical Trials

An Investigational New Drug (IND) application must be submitted to the FDA before clinical trials of a new drug can be initiated. This document provides information related to manufacturing information, animal study data, clinical protocols and all data about principal investigators.

The clinical research stage of drug development starts when preclinical research is completed and a new drug (or device) is ready to be tested in humans. Clinical trials are the only way to evaluate how a medication will affect a person's body in real world settings. Clinical trials are carefully planned in order to maximize safety and minimize risks to participants, which includes determining how many people will be involved, how long testing will last, and what tests will be carried out during the clinical trials stage. During this phase of clinical research, everything must adhere to strict FDA guidelines.

Clinical trials are typically broken down into four phases, which include those below.

  • Phase 0 clinical trials: testing the effect of micro doses of an investigational drug in study participants
  • Phase 1 clinical trials: testing the effects of full doses of an investigational drug in study participants, typically focused on identifying potential toxicities and optimal dosing
  • Phase 2 clinical trials: testing the effects of full doses of an investigational drug in a limited number of study participants, typically focused on evaluating the potential therapeutic benefits and any side effects
  • Phase 3 clinical trials: testing the effects of full doses of an investigational drug in a larger group of study participants, typically focused on evaluating the potential therapeutic benefits and any side effects
  • Phase 4 clinical trials: continued surveillance of newly approved drugs to monitor therapeutic benefits and any side effects For more information about these, visit clinical trial phases.

FDA Review and Approval

Once the clinical trial is completed, the researchers submit a New Drug Application (NDA) to the FDA. This application details the drug's safety and efficacy from clinical trials and requests that the new drug is approved for use by the public. It will necessitate a large amount of data, including information on all phases of research, clinical results, safety precautions, and probable drug interactions. It can take approximately six to ten months for the evaluation to be completed by the FDA.

Post-Approval Research & Monitoring

After FDA approval, pharmaceutical companies will continue to monitor how the drug performs in real world settings by establishing registries of patients and conducting post-marketing surveys. The information collected through these research processes can help the company adjust dosing, identify drug-drug interactions, discover prospective alternate uses and uncover unwanted and unexpected significant side effects.

Drug development is an intense process that takes many years from initial identification of a drug target (e.g., specific proteins, molecules or metabolites) to the approval of a new medication. Key players are involved in each stage, from the pharmaceutical chemists and researchers involved at drug discovery to the all-important study participants that take part in clinical trials to bring innovative and effective new drugs to market.

If you are interested in joining a study, you can use to search clinical trials near you and learn more about what is available.

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