4 Ways Altasciences Can Help Maximize Drug Formulation for First In Human Clinical Trials

1. 4 Ways Altasciences Can Help Maximize Drug Formulation for First In Human Clinical Trials

2. 4 Ways Altasciences Can Help Maximize Drug Formulation for First In Human Clinical Trials Are you trying to determine a formulation for your pharmaceutical drug before you take it to first in human clinical trials? It might be time to partner with Altasciences for support. As an integrated CRO/CDMO, Altasciences is ready to help your organization maximize your drug formulation before clinical trials, during bioanalysis, and through manufacturing. Here are four drug formulation considerations and how Altasciences can help. How Formulation Effects Drug Development The primary objective of a first-in-human trial is to determine the starting dose of a new drug. It has to be low enough to provide low or no safety and toxicity risks while still having the highest dosage and benefit for the intended trial. Manufacturing the drug correctly for the study is essential. Formulation, manufacturing, and assessing the drug candidate during the study are all contributing factors to whether the drug can safely deliver the correct dosage and whether it gains regulatory approval. Because Altasciences is an integrated CRO/CDMO, information gathered during the early phases of drug development can be incorporated into the

3. manufacturing process during both clinical trials and when you’re ready to bring the drug to market. Formulation Development First, you will need to develop a dosage that can be produced efficiently and cost-effectively. It should meet quality specifications. Often this takes the form of oral liquids, tablets, capsules, or powders. Some advanced drug delivery systems, like nanoparticles, result in more complex formulations and manufacturing processes. Many of these formulations will fail, even if they make it through clinical trials. Key performance characteristics, including bioavailability and solubility, are easily achieved in simple FIH formulations but are harder to replicate in late-stage trials and commercial use with more complex dosage forms. Since their team has worked with nearly all dosage forms available on the market, Altasciences has the experience to help you determine the formulation. Bioavailability Bioavailability is, among other key characteristics, critical to the formulation. It’s one of the characteristics Altasciences can analyze with its bioanalytical services, especially if you invest in more than one dosage form. This, in turn, helps find the best combination of the active pharmaceutical ingredient and excipient. Plus, changes can be made quickly. This minimizes waste that can result from dosage form size. Formulation and Participant Safety A primary concern in drug development is safety, especially with novel drug products starting FIH trials. Altasciences can help your organization establish safety protocols and help design the study. These are important as they can carry over to later stages of clinical trials, such as CNS clinical trials. High-risk candidates, for example, might be better for intravenous administration. It’s easy to stop slow intravenous infusions if an adverse reaction occurs. Partner with Altasciences for help formulating your drug at https://www.altasciences.com/ Original Source: https://bit.ly/39ehy9s