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  • Describe the types of safety and efficacy risks that may occur after taking a drug product and various means for preventing these risks.

  • List the major reasons that a drug product might be recalled due to quality defects.

  • Understand how biopharmaceutics risk assessment road map (BioRAM) can lead to rational drug product development.

  • Differentiate between drug product quality and drug product performance.

  • Differentiate between quality control (QC) and quality assurance (QA).

  • Explain how quality by design (QbD) ensures the development and manufacture of a drug product that will deliver consistent quality and performance.

  • Define quality target product profile (QTPP) and explain how QTPP is different from conventional quality product criteria.

  • Describe the quality principles underlying basis for the development, manufacture, and QA of the drug product throughout its life cycle.

  • Describe how product specifications relate to drug product quality and the relevance to QA of the drug product through QbD.

  • Define critical quality attributes and how these attributes relate to clinical safety and efficacy.

  • Explain how postapproval changes in a drug product may affect drug quality and performance.

Biopharmaceutics is the study of the relationship between physicochemical properties of the drug, the dosage form (drug product) in which the drug is given and the route of administration on the rate and extent of systemic absorption. As such, the design (development and mechanism of delivery) of drug product and its quality have a big impact on the safety and efficacy of the drug. In this chapter, we explore the impact of drug product formulation on its safety/efficacy (biopharmaceutics) and the ways of assuring the quality and performance of the product throughout the life cycle of the drug.


Side effects from the use of drugs are the major cause of drug-related injuries, adverse events, and deaths. The FDA (FDA, 2005, 2007) has summarized various types of safety and efficacy risks from medicines (Fig. 27-1). Side effects are observed in clinical trials or postmarketing surveillance and result in listing of adverse events in the drug’s labeling. Some side effects are avoidable, and others are unavoidable. Avoidable side effects may include known drug–drug or drug–food interactions, contraindications, improper compliance, etc. In many cases, drug therapy requires an individualized drug treatment plan and careful patient monitoring. Known side effects occur with the best medical practice and even when the drug is used appropriately. Examples include nausea from antibiotics or bone marrow suppression from chemotherapy. Medication errors include wrong drug, wrong dose, or incorrect drug administration. Some side effects are unavoidable. These uncertainties include unexpected adverse events, side effects due to long-term therapy, and unstudied uses and unstudied populations. For example, a rare adverse event occurring in fewer than 1 in 10,000 persons would not be identified in normal premarket testing. Chapters 21, 22, and 23 discuss how pharmacogenetics, pharmacokinetics, pharmacodynamics, and clinical considerations may improve drug efficacy ...

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