Medical Qualification Determinations. Final rule

    Federal Register
    |January 20, 2017
    PubMed

    Related Concept Videos

    Determination01:51

    Determination

    During embryogenesis, cells become progressively committed to different fates through a two-step process: specification followed by determination. Specification is demonstrated by removing a segment of an early embryo, “neutrally” culturing the tissue in vitro—for example, in a petri dish with simple medium—and then observing the derivatives. If the cultured region gives rise to cell types that it would normally generate in the embryo, this means that it is specified. In...
    21.3K
    Determination of Renal Drug Clearance: Graphical and Midpoint Methods01:07

    Determination of Renal Drug Clearance: Graphical and Midpoint Methods

    Renal clearance, a crucial parameter in pharmacokinetics, can be determined using two different methods: the graphical method and the midpoint method. These methods provide insights into the rate of drug excretion by the kidneys and aid in assessing renal function.
    The graphical method involves plotting the rate of drug excretion in urine against the plasma drug concentration. By analyzing the graph, the clearance can be calculated and obtained. Drugs rapidly excreted by the kidneys exhibit a...
    454
    Determination of Multiple Dosing Parameters: Steady-State, Minimum and Maximum Concentrations01:15

    Determination of Multiple Dosing Parameters: Steady-State, Minimum and Maximum Concentrations

    Gentamicin, an aminoglycoside antibiotic, is commonly administered via intermittent intravenous infusion to treat severe infections. An intermittent one-hour infusion of gentamicin, administered at eight-hour intervals, allows for precise control of plasma drug concentrations, minimizing toxicity while ensuring therapeutic efficacy. Pharmacokinetic principles govern the dynamics of plasma concentrations and can be mathematically described using specific equations.The plasma drug concentration...
    305
    Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

    Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

    PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
    58
    FDA Approved Drugs: Changes to Approved Drugs01:26

    FDA Approved Drugs: Changes to Approved Drugs

    Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
    302
    Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

    Clinically Relevant Drug Product Specifications: Methods of Establishment

    Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
    275