AMCP Guide to Pharmaceutical Payment Methods

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    Pharmaceutical Equivalents01:26

    Pharmaceutical Equivalents

    As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
    Drug Dosage Regimen: Overview01:15

    Drug Dosage Regimen: Overview

    A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
    Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
    Routes of Drug Administration: Parenteral01:25

    Routes of Drug Administration: Parenteral

    The administration of drugs via parenteral routes allows for direct drug introduction into the systemic circulation, resulting in high bioavailability because the medication bypasses the harsh conditions of the gastrointestinal tract and hepatic metabolism.
    The intravenous route (IV) of drug administration can be further categorized into two types. The bolus injection administers the entire dose rapidly, while an intravenous infusion slowly delivers smaller doses steadily.
    The IV route is often...
    Measurement of Bioavailability: Pharmacodynamic Methods01:20

    Measurement of Bioavailability: Pharmacodynamic Methods

    Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
    Dosage Interval and Administration Route: Determination Methods01:19

    Dosage Interval and Administration Route: Determination Methods

    A medication’s effectiveness largely depends on its appropriate dosage and the route of administration. Dosage ensures that a sufficient drug concentration is maintained in the bloodstream to elicit the desired therapeutic effect without causing toxicity. The route of administration affects the drug's bioavailability, rate of absorption, and onset of action, which are crucial for achieving optimal therapeutic outcomes. Drug dosage calculations are critical to tailoring therapy to individual...
    Dosage Regimens: Designs and Approaches01:28

    Dosage Regimens: Designs and Approaches

    Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...