Drug Product Performance
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Luna Abigail TorresDrug Product Performance
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Luna Abigail TorresDRUG PRODUCT PERFORMANCE Drug disposition – drug distribution and elimination
Drug product – variety of dosage forms such as solids, semisolids, liquids, The experimental aspect of pharmacokinetic involves the development of biologic
suspensions, emulsions etc for systemic or local therapeutic activity. sampling techniques, analytical methods for the measurement of drugs and
- Can be considered to be the drug delivery systems that release and deliver drug metabolites, and procedures that facilitate data collection and manipulation.
to the site of action such that they produce the desired therapeutic effect. The theoretical aspect of pharmacokinetics involves the development of
- Designed to specifically meet the patient’s need including palatability, pharmacokinetic models that predict drug disposition after drug administration.
convenience and safety Classical pharmacokinetics is a study of theoretical models focusing mostly on
Drug product performance – the release of the drug substance from the drug model development and parameterization.
product either for local drug action or for drug absorption into the plasma for PHARMACODYNAMICS
systemic therapeutic activity. - The study of the biochemical and physiological effects of drugs on the body; this
BIOPHARMACEUTICS includes the mechanisms of drug action and the relationship between drug
- Examines the interrelationship of the physical/chemical properties of the drug, concentration and effect.
the dosage form (drug product) in which the drug is given, and the route of - How a drug interacts quantitatively with a drug receptor to produce a response
administration on the rate and extent of systemic drug absorption (effect)
- Provides the scientific basis for drug product design and drug product - Pharmacodynamic effect sometimes referred to as the pharmacologic effect,
development can be therapeutic and/or cause toxicity
- Involves factors that influence (1) the design of the drug product (2) stability of - Pharmacodynamic effect is dose/drug concentration related; the higher the
the drug within the drug product (3) the manufacture of the drug product (4) dose, the higher drug concentrations in the body and the more intense the
the release of the drug from the drug product (5) the rate of dissolution/release pharmacodynamics effect up to a maximum effect.
of the drug at the absorption site (6) delivery of the drug to the site of action - Side effects and/or toxicity of drugs occurs at higher drug concentration than
- Based on fundamental scientific principles and experimental methodology the drug concentrations needed for the therapeutic effect.
A pharmacodynamics response results when the drug concentration at the site of CLINICAL PHARMACOKINETICS
action reaches or exceeds the minimum effective concentration (MEC) - The application of pharmacokinetic methods to drug therapy
Bioavailability – a measure of systemic availability of a drug. Subtherapeutic – drug concentration below the MEC
In vitro methods are procedures employing test apparatus and equipment without Toxic – drug concentration above the minimum toxic concentration
involving laboratory animals or humans.
In vivo methods are more complex studies involving human subjects or laboratory
animals.
PHARMACOKINETICS
- The science of the kinetics of drug absorption, distribution, and elimination (ei,
metabolism and excretion).
