Drug product will follow you all the way through the clinical trials and into the commercial supply to healthcare systems and the patients.
Key features of drug product formulation:
The orphan drug product (DP) you develop is what the patients will encounter and what medicinal agencies will approve. What you develop will most probably influence patients’ lives in a tremendous way, potentially curing them and improving quality of their lives like nothing else has done before. The formulation of the DP will thus play a big role in how patients perceive the drug, how it becomes a part of their lives, and how they structure their life around it.
The formulation you choose will influence following key features of your DP:
- Efficacy: DP is absorbed in a body and acts in line with its purpose
- Safety: DP is non-toxic for patients, minimizes risk for local side effects and may adjust for therapeutic windows of drug substance
- Stability: Drug substance does not decompose
- Uniformity of dosage: Same dosage with same effect is administered at every occasion
- Appearance: DP is compliant to patients
- Price: The cost of the final product is accepted by healthcare systems
- Patient acceptability: It is easy to use and dose the product both by patients and potentially healthcare providers
- Patentability: The formulation provides novelty, rising possibility to protect your invention for a certain part of its commercial lifetime.
We are thrilled to announce that APL are joining us as a sponsor at this year’s World Orphan Drug Congress USA 2016. Register today to meet them in D.C. on April 20-22.