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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

248
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,...
248
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

190
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.
190
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

181
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...
181
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

425
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...
425
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

178
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...
178
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

160
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,...
160

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Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
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Pharmaceutical Approval Update.

Michele B Kaufman

    P & T : a Peer-Reviewed Journal for Formulary Management
    |May 14, 2019
    PubMed
    Summary
    This summary is machine-generated.

    New drug approvals offer hope for rare diseases. Cablivi treats acquired thrombotic thrombocytopenic purpura, Egaten targets fascioliasis, and Spravato addresses treatment-resistant depression.

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    Area of Science:

    • Pharmacology and Therapeutics
    • Hematology
    • Infectious Diseases
    • Psychiatry

    Background:

    • Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare, life-threatening autoimmune disorder.
    • Fascioliasis is a neglected tropical disease caused by liver fluke parasites.
    • Treatment-resistant depression (TRD) poses a significant challenge in mental healthcare.

    Purpose of the Study:

    • To review the efficacy and safety of newly approved medications for specific conditions.
    • To highlight advancements in therapeutic options for aTTP, fascioliasis, and TRD.
    • To inform healthcare providers and researchers about novel treatment modalities.

    Main Methods:

    • Review of clinical trial data and regulatory submissions for Cablivi (caplacizumab-yhdp), Egaten (triclabendazole), and Spravato (esketamine).
    • Analysis of pharmacokinetic and pharmacodynamic profiles.
    • Assessment of adverse event profiles and patient outcomes.

    Main Results:

    • Cablivi demonstrated significant reduction in thrombotic microangiopathy complications in aTTP patients.
    • Egaten showed high efficacy in clearing parasitic infections in fascioliasis.
    • Spravato provided rapid antidepressant effects in patients with TRD who had inadequate response to other treatments.

    Conclusions:

    • Caplacizumab represents a targeted therapy for aTTP, improving clinical outcomes.
    • Triclabendazole remains a cornerstone treatment for fascioliasis.
    • Esketamine offers a novel therapeutic option for severe depression, necessitating careful monitoring.