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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

257
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,...
257
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

201
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.
201
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

192
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...
192
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

499
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...
499
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

182
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...
182
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

161
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,...
161

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Pharmaceutical Approval Update.

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    P & T : a Peer-Reviewed Journal for Formulary Management
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    Summary
    This summary is machine-generated.

    New inhaled levodopa (Inbrija) treats Parkinson's "off" episodes. Ravulizumab (Ultomiris) treats paroxysmal nocturnal hemoglobinuria. Revefenacin (Yupelri) is for COPD maintenance.

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    Area of Science:

    • Pharmacology and Therapeutics
    • Respiratory Medicine
    • Neurology

    Background:

    • Parkinson's disease presents challenges with "off" episodes, impacting motor function.
    • Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disorder requiring effective treatments.
    • Chronic Obstructive Pulmonary Disease (COPD) necessitates long-term management strategies.

    Purpose of the Study:

    • To review the therapeutic applications of three novel pharmaceutical agents.
    • To highlight Inbrija for Parkinson's disease "off" episodes.
    • To discuss Ultomiris for PNH and Yupelri for COPD maintenance therapy.

    Main Methods:

    • Review of clinical trial data and prescribing information.
    • Analysis of efficacy and safety profiles for each drug.
    • Assessment of patient populations and treatment indications.

    Main Results:

    • Inbrija demonstrated efficacy in rapidly treating Parkinson's "off" episodes.
    • Ultomiris showed effectiveness in managing PNH.
    • Yupelri provided a new option for maintenance treatment in COPD patients.

    Conclusions:

    • Inbrija offers a new inhaled option for Parkinson's disease symptom management.
    • Ultomiris provides an effective treatment for PNH.
    • Yupelri expands therapeutic choices for COPD patients.