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    Problems in Designing Studies for Pharmaceutical Development: Patients, Prescriptions, and Physicians

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    More palatable pharmaceuticals mean easier administration, better compliance with prescription requirements, and less unpleasantness associated with illness. Developing the best possible taste, smell and texture for a pharmaceutical product requires the presence of the active ingredient; its taste or smell has to be masked or mitigated. With an active ingredient present, the respondent must be a “patient,” someone who uses this product when needed.

    Some of the factors that determine the research design are: (1) the status of the product, is it “over the counter” (OTC) or prescription, and (2) the need to conduct tests among symptomatic patients versus asymptomatic individuals. In the case of OTC products, research designs must often be submitted to an Institutional Review Board (IRB), so that an independent group of specialists, including a physician, can determine that the project is conducted in an ethical manner. IRBs are required when nonphysicians administer pharmaceuticals. In the case of prescription drugs, physicians must be employed to place products with their patients when illness calls for the particular drug under investigation.

    With regard to the presence or absence of symptoms, consider that tests of liquid cold remedies or nasal decongestants require symptomatic individuals since sensory acuities are altered by nasal decongestion. On the other hand, antacid tests do not require the presence of symptoms when the issues are taste and texture.

    Case studies are presented to demonstrate the complexities of sensory research for OTC and prescription products.


    over the counter (OTC), Institutional Review Board (IRB), symptomatic, asymptomatic

    Author Information:

    Fishken, D
    President, Sensory Resources, Newton, MA

    Committee/Subcommittee: E18.94

    DOI: 10.1520/STP15877S