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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

247
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

189
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.
189
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...
179
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...
408
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...
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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

156
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.

Mary Choy

    P & T : a Peer-Reviewed Journal for Formulary Management
    |July 2, 2019
    PubMed
    Summary
    This summary is machine-generated.

    This summary covers Mavenclad for relapsing multiple sclerosis (MS), Duaklir Pressair for chronic obstructive pulmonary disease (COPD), and Evenity for osteoporosis, highlighting new treatment options.

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    Area of Science:

    • Pharmacology and Therapeutics
    • Neurology
    • Pulmonology
    • Endocrinology

    Background:

    • Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
    • Chronic obstructive pulmonary disease (COPD) is a progressive lung disease.
    • Osteoporosis is a skeletal disorder characterized by compromised bone strength.

    Purpose of the Study:

    • To review the efficacy and safety of Mavenclad (cladribine) for relapsing forms of MS.
    • To assess the utility of Duaklir Pressair (aclidinium bromide/formoterol fumarate) in managing COPD symptoms.
    • To evaluate the effectiveness of Evenity (romosozumab-aqqg) in treating osteoporosis.

    Main Methods:

    • Review of clinical trial data and post-marketing surveillance for each drug.
    • Analysis of patient outcomes, including disease activity, symptom control, and bone mineral density.
    • Assessment of adverse event profiles and contraindications.

    Main Results:

    • Mavenclad demonstrated significant reduction in MS relapse rates and disability progression.
    • Duaklir Pressair provided sustained bronchodilation and improved lung function in COPD patients.
    • Evenity showed rapid and substantial increases in bone mineral density and reduction in fracture risk.

    Conclusions:

    • Mavenclad is an effective oral option for relapsing MS.
    • Duaklir Pressair offers a valuable therapeutic option for COPD management.
    • Evenity represents a significant advancement in osteoporosis treatment, particularly for high fracture risk patients.