What primary information must be included in an IND submission regarding the drug's composition?

The inclusion of active and inactive ingredients in an Investigational New Drug (IND) submission is essential because it provides critical information regarding the formulation of the drug. This information enables regulatory authorities, such as the FDA, to evaluate the safety and efficacy of the drug by understanding what components are present. Active ingredients are those that contribute to the therapeutic effect, while inactive ingredients help in stabilizing the drug or facilitating its delivery. Both types of ingredients must meet specific regulatory standards, and any changes to their composition can affect the drug's performance and safety profile.

In contrast, detailed marketing plans, pricing strategies, and production locations do not directly pertain to the IND submission's core purpose, which is to facilitate the assessment of the drug's safety for clinical trials. While marketing strategies and pricing may be relevant later in the drug development process, they are not part of the primary information required for IND submissions. Likewise, while production locations may play a role in quality control, they are not a requirement for the initial assessment of the drug's composition. Thus, the focus on active and inactive ingredients is vital for ensuring that the regulatory authority has the necessary data to proceed with the clinical evaluation of the drug.