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Phase 1 and Phase 2 clinical trials

The goal of clinical trials is to identify whether a designated treatment will benefit an identified population. This process applies to brand-new treatments that develop as well as treatments that were developed with the intention of replacing an older, less effective one.

From start to finish, the process of developing medicine is conducted methodically. Once your formulation has been scaled up and is ready to be tested on the intended human population, it is time to move on in the process to Phase 1 and Phase 2 clinical trials.

Phase 1 Clinical Trials

During a Phase 1 clinical trial, the goal is ultimately to evaluate the safety of a drug. It is often started with a smaller sample of healthy individuals who volunteer to be tested on. This gives insight into how the drug will impact the overall population and sparks research questions for Phase 2 clinical trials.

The Process

In the process of Phase 1 clinical trials, the group is first injected with a small dose of the medicine and monitored. Often, researchers are looking for severe side effects, since this is the first time the drug is being tested on the intended population. It is also common to look for the amount of a drug that is in the blood after administration and the overall effects of the drug on the body.

Researchers may also look for the side effects associated with increasing the dosage of the drug. This is helpful in determining the maximum dosage of the drug that can be administered without side effects. After notes are taken, they are evaluated and researched before moving onto Phase 2 of a clinical trial.

Phase 2 Clinical Trials

In a Phase 2 clinical trial, the goal is to perfect the dosage and test its effectiveness. Ultimately, this equates to the idea of maximizing benefits while minimizing risks to the user. In this step, the medicine is rigorously tested for its success in treating, preventing, or diagnosing a problem or disease.

The Process

During Phase 2 clinical trials, it is typical to test a much larger sample to better understand the drug’s effectiveness. Phase 2 can be thought of as comprising two halves. The first half focuses on dosing, where patients are given different amounts of the drug. It is important to carefully monitor changes when administering different doses. The second half of the trial is reserved for testing the efficacy of the drug.

After these steps are completed, the drug is then evaluated for its benefits and risks. Should the benefits outweigh the risks of the drug, the testing moves on to Phase 3 clinical trials for further assessment.

Choose Oakwood Labs as Your Clinical Trial Destination

Your Phase 1 and 2 clinical trials are critical to providing the public with effective medicine. The testing that needs to be conducted to make sure drugs are safe and effective for patients is extensive. When you discover a new drug that you want to take to market, it is important to be supported by a team that is both knowledgeable and experienced.

Oakwood Labs has the environment and qualified team needed to assist in the development of your treatment. Since 1997, our team has been providing therapeutic benefits to patients through the use of sustained-release pharmaceutical injectables. We operate in a fully FDA-compliant aseptic manufacturing facility to enhance our development capabilities and range of services.

Additionally, we have the ability to help with other projects. We offer the following services, making us the source for supporting all phases of long-acting injectable development:

Choose Oakwood Labs as Your Clinical Trial Destination

Oakwood Labs is equipped with the supplies, team, and facilities to help you plan and execute Phase 1 and 2 clinical trials. Contact us today to get started on your next project.

Dallas, TX

This year’s PDA Annual Meeting is occurring April 4-6 in Dallas, TX. This event is focused on the theme of “Level Up: Agility in the New Normal” and will highlight items to look forward to in the future of pharmaceutical manufacturing.

Incorporating speakers, networking events, and panel discussions, this is an event that you will not want to miss. This year, we are excited to announce that we will be featured as an exhibitor.

We Look Forward to Seeing You

Our team has been focused on researching and developing sustained-release injectables, and we are always looking for opportunities to chat about our discoveries and processes. If you are looking for an aseptic lab staffed by experts, consider Oakwood Labs for your next project, as we can assist you in the following:

  • Pre-formulation development activities
  • Feasibility studies
  • Scale-up of formulation
  • Manufacturing toxicology batches
  • ICH compliant stability testing
  • Clinical trial manufacturing (Phase I, II, III)
  • Commercial aseptic GMP manufacturing

We are so excited to meet you and show you what we have been working on, so be sure to come to visit the Oakwood Labs team at Booth #308.

Don’t Hesitate to Reach Out

The 2022 PDA Annual Meeting is sure to inform us about new trends and inspire us to be innovative as we take on the pharmaceutical challenges that lie ahead. If you are unable to attend the event, we would be happy to chat about our experience at the occasion or provide information on extended-release technology and more.

Reach out today with any questions you may have. We look forward to seeing you soon!