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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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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,...
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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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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.
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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Pharmaceutical Approval Update.

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    P & T : a Peer-Reviewed Journal for Formulary Management
    |June 14, 2018
    PubMed
    Summary
    This summary is machine-generated.

    Three novel therapies, burosumab-twza (Crysvita), ibalizumab-uiyk (Trogarzo), and tildrakizumab-asmn (Ilumya), offer new treatment options for rare inherited rickets, HIV-1 infection, and plaque psoriasis, respectively.

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    Area of Science:

    • Pharmacology and Therapeutics
    • Medical Treatments
    • Drug Approvals

    Background:

    • Rare inherited disorders like rickets pose significant health challenges.
    • Human immunodeficiency virus type 1 (HIV-1) infection remains a global health concern.
    • Moderate-to-severe plaque psoriasis impacts a substantial patient population, affecting quality of life.

    Purpose of the Study:

    • To review the therapeutic applications of three recently approved drugs.
    • To highlight advancements in treating rare genetic diseases.
    • To discuss new options for managing chronic viral infections and autoimmune conditions.

    Main Methods:

    • Review of clinical trial data and regulatory submissions for burosumab-twza, ibalizumab-uiyk, and tildrakizumab-asmn.
    • Analysis of efficacy and safety profiles for each therapeutic agent.
    • Synthesis of information regarding indications and patient populations.

    Main Results:

    • Burosumab-twza (Crysvita) demonstrates efficacy in treating a rare inherited form of rickets.
    • Ibalizumab-uiyk (Trogarzo) provides a new therapeutic avenue for human immunodeficiency virus type 1 (HIV-1) infection.
    • Tildrakizumab-asmn (Ilumya) is approved for adults with moderate-to-severe plaque psoriasis.

    Conclusions:

    • These novel therapies represent significant progress in their respective medical fields.
    • Burosumab-twza, ibalizumab-uiyk, and tildrakizumab-asmn expand treatment paradigms.
    • The availability of these drugs offers improved management strategies for patients with rickets, HIV-1, and psoriasis.