How Altasciences Can Help with NDA-Enabling Studies

1. How Altasciences Can Help with NDA How Altasciences Can Help with NDA- -Enabling Studies Enabling Studies

2. How Altasciences Can Help with NDA How Altasciences Can Help with NDA- -Enabling Studies Studies Enabling Altasciences has more than 25 years of experience designing and conducting various early phase studies required for new drug application (NDA) studies. Altasciences is an integrated CRO/CDMO, and their team has expertise in both stand-alone studies and complete early clinical development early clinical development programs. This full-service CRO focuses on safety, quality, animal welfare, and the ability to recruit and retain potential participants for clinical studies. Here are some of the NDA-enabling studies they can assist with. Single Ascending Dose Studies Single Ascending Dose Studies One requirement for NDA submissions is single ascending dose, or SAD, studies. First in human clinical trials human clinical trials are used to assess a single dose of your compound. The dose is then increased until the maximum exposure is reached. Altasciences works closely with partners to design SAD studies. They prepare a detailed risk assessment to determine the appropriate starting dosage and escalation. Plus, Altasciences offers specialized safety monitoring equipment for these trials. Multiple Ascending Dose Studies Multiple Ascending Dose Studies Multiple ascending dose, or MAD, studies are required for almost all NDA submissions. Rare exceptions include drugs that are only given to a patient one time. Dose levels and intervals need to be determined, as well as pharmacokinetics and sometimes pharmacodynamics of multiple doses of your compound. Altasciences has facilities First in

3. equipped with all the amenities you need to help make these studies attractive to potential study participants. They are ideal for recruiting and retaining participants for longer overnight studies, which are common strategies for MAD trials. PK Bridging and Bi PK Bridging and Bioavailability Studies oavailability Studies Bioavailability and pharmacokinetic (PK) bridging studies are often clinical development requirements. For example, you might need to compare the PK of new and old formulations. Altasciences’ full-service model supports all aspects of innovator drug development, and the team routinely designs, conducts, and prepares reports for PK bridging and bioavailability studies. Food Effect Studies Food Effect Studies If your drug is taken orally, a food effect study is required. Other requirements for food effect studies vary. These can be part of multiple early phase studies with adaptive designs. They are used to assess the absorption of your compound when administered with food, like a high-fat breakfast, for instance. The Altasciences team specializes in conducting studies under umbrella protocols, such as FIH studies combined with other early efficacy assessment studies, as well as independent studies. Renal and H Renal and Hepatic Impairment Studies epatic Impairment Studies Renal and hepatic impairment studies may be necessary if the drug is excreted through the kidneys or liver, respectively. These trials require impaired patients in a hospital setting. Altasciences has alliances with local hospitals and leading research centers to provide you with access to patients experiencing renal or hepatic impairment. Depending on the study, Altasciences can offer full project management and adaptive designs. This includes multi-site trials, operational support, customized protocol design, biostatistics and bioanalysis bioanalysis, data management, and reporting. Partner with Altasciences for https://www.altasciences.com/ https://www.altasciences.com/ Original Source: https://bit.ly/3E6MP8Y your NDA-enabling studies at