Clinical Trial Conduct

The product's characteristics are often referred to as the product's profile, which initially is the ideal list for a successful product. The profile will change over time as more information from research is uncovered, and the final profile for the NDA will ultimately be described in the product's package insert.

As described in Chapter 2, a product's profile is a realistic description of the new product's characteristics when it is ultimately marketed. Ideally, it should describe the key properties of the product such as efficacy, safety, and formulation information (Fig. 8.7). It may also contain information on the product relative to other similar products that will be based on active controlled trials to be done. Having an understanding of the product's ideal profile to meet patient care and the market needs is critical to the planning process and should be the first task of the project team. The profile is based on the disease, treatment needs, and any early product data, and it evolves over time as studies are done and information is available. Once the product profile is completed, the package insert may be drafted. The overall goal of drug development is to complete a package insert for the NDA (i.e., keep the end in mind). A package insert may be completed in conjunction with the product profile as it provides the framework for describing the product's characteristics.

The package insert (PI) provides the end users (physician, pharmacist, and nurse) of the product with information required to ensure the safety of each patient taking the product, along with patient selection (indication), proper dosing and administration (Fig. 8.8). It is required for all marketed r The Product Profile, ideally:

c Describes key properties of the product:

$> Efficacy, safety, formulation, & dosing & administration. May contain comparative information, e.g., product competitors.

o Should be first task for a project team:

> Overall goal of drug development is to develop a package insert for marketing the product.

The Package Insert (PI) - Goals: o Provide end user (MD, PharmD, RN) product information. o Is required by law for all marketed drugs. o Drives number and type of clinical trials required. o Drives indication, dosing, administration, & formulation.

Information required in PI is described in CFR: c Usage Information: 5> Description

> Clinical Pharmacology S> Indications and Usage

S> Dosage and Administration

> How Supplied o Safety Information:

> Contraindications

ï> Warnings and Precautions

Adverse Reactions

Drug Abuse and Dependence

S> Overdosage Fig. 8.8. Package Insert

Product profile & PI drive development plan.

Full development plan:

c Time & Events:

Clinical, manufacturing, pharmacology/toxicology, regulatory

Formulations, safety, QA-stability, package engineering o All studies for desired PI

p Resource requirements c Budgets c Role of scientific advisory boards & focus groups c Publication plans

Fig. 8.9. Development Plan

Acute

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