Bio-pharmaceutics

Drugs are in a dynamic state within the body as they move between tissues and fluids, bind with plasma or cellular components, or are metabolized. The biological nature of drug distribution and disposition is complex, and drug events often happen simultaneously. Such factors must be considered when designing drug therapy regimens. The inherent and infinite … Read more

Measurement of drug concentrations Because drug concentrations are an important element in determining individual or population pharmacokinetics, drug concentrations are measured in biological samples, such as milk, saliva, plasma, and urine. Sensitive, accurate, and precise analytical methods are available for the direct measurement of drugs in biologic matrices. Such measurements are generally validated so that … Read more

What is Clinical Pharmacokinetics? During the drug development process, large numbers of patients are enrolled in clinical trials to determine efficacy and optimum dosing regimens. Along with safety and efficacy data and other patient information, the FDA approves a label that becomes the package insert discussed in more detail later in this chapter. The approved … Read more

Drug product performance Drugs are compounds that are meant to be used in the diagnosis, treatment, mitigation, or prevention of disease. For systemic or local therapeutic activity, drugs are delivered in a range of dosage forms or drug products, such as solids (tablets, capsules), semisolids (ointments, creams), liquids, suspensions, emulsions, and so on. Drug products … Read more