drugs (i.e., required by law). The PI is a legal document affecting patient care. The planned PI drives indication, dosing, administration, and formulation to be used in clinical trials and also drives number and type of clinical trials required for the NDA/CTD in the development plan. The information required in the package insert is described in 21 CFR 201.56 and includes the 11 sections outlined on Fig. 8.8 [3]. The package insert may contain additional sections if appropriate and in compliance with the regulations. These sections may include animal pharmacology and/or animal toxicology, clinical studies (excepts of design and data), and references.

The clinical studies required to complete many of these sections are pivotal to the overall success of the development program. Once the proposed product profile and package insert are drafted and approved by management for a new drug, the clinical trials may begin to be planned and designed, along with additional nonclinical work as necessary. Therefore, the product profile and associated package insert will drive the development plan for the product and, ultimately, the clinical plan.

The development plan engages the whole company (all divisions, all staff involved at any stage in any way) and will contain all studies to be done (basic research and clinical), all resources, budgets, and potential publications (Fig. 8.9). Many representative departments in six divisions from across the example company are engaged and listed below. Any staff, budgets, and systems are included in the development plan. Input for the plan includes outside experts, who serve on company advisory boards and participate in focus groups where specific development ideas are discussed. Scientific and marketing information is shared. These boards and groups include experts with knowledge in the disease, drugs, health care environment, and payor situations. They provide invaluable reality checks for the company's clinicians, researchers, and marketers, as well as feedback on the products and plans of the company. The studies done by the company need to be published to communicate new findings to the medical community and public and receive peer review and acceptance based on good science. Especially with breakthrough products where existing knowledge is lacking, a full-blown education plan for the medical community is needed to establish the scientific basis for the new product and how it fits and exceeds existing therapy.

An example of a drug development plan is provided also on this Figure 8.9. A budget also would be associated with each activity. A basic development plan will contain the time, events, and responsible parties for the drug development activities for the following six company divisions (16 representative functional groups).

• Clinical trials (clinical operations, safety, medical affairs, pharmacokinetics (ADME), CDM, biostatistics, pharma-coeconomics)

• Manufacturing (formulations, package engineering, QC [stability])

• Research (pharmacology, toxicology)

• Regulatory and Legal

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