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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,...
273
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

189
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...
189
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

569
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

179
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
    |May 3, 2018
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    Summary
    This summary is machine-generated.

    New treatments include Vancomycin hydrochloride for oral solution (Firvanq) to combat C. difficile infections and S. aureus enterocolitis. Dexamethasone intraocular suspension (Dexycu) and apalutamide (Erleada) offer new options for post-surgery eye inflammation and prostate cancer, respectively.

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    Area of Science:

    • Pharmacology and Therapeutics
    • Oncology
    • Ophthalmology

    Background:

    • Antibiotic resistance and specific infections necessitate novel therapeutic agents.
    • Post-surgical ocular inflammation requires effective and targeted treatments.
    • Advanced prostate cancer management seeks improved therapeutic options.

    Purpose of the Study:

    • To introduce and review new pharmaceutical agents for distinct medical conditions.
    • To highlight the clinical utility of Vancomycin hydrochloride, dexamethasone intraocular suspension, and apalutamide.
    • To provide an overview of recent advancements in treating C. difficile-associated diarrhea, S. aureus enterocolitis, post-operative eye inflammation, and prostate cancer.

    Main Methods:

    • Review of clinical trial data and regulatory submissions for new drug approvals.
    • Analysis of pharmacokinetic and pharmacodynamic properties of the agents.
    • Evaluation of efficacy and safety profiles in target patient populations.

    Main Results:

    • Vancomycin hydrochloride (Firvanq) demonstrated efficacy in treating C. difficile-associated diarrhea and S. aureus enterocolitis.
    • Dexamethasone intraocular suspension 9% (Dexycu) proved effective in reducing post-eye surgery inflammation.
    • Apalutamide (Erleada) showed significant therapeutic benefit in patients with prostate cancer.

    Conclusions:

    • The approved agents represent significant advancements in their respective therapeutic areas.
    • Firvanq, Dexycu, and Erleada offer new, targeted treatment options for clinicians and patients.
    • These novel therapies underscore the ongoing progress in pharmaceutical development for infectious diseases, ophthalmology, and oncology.