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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

269
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,...
269
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

203
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.
203
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...
200
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

188
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...
188
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

540
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...
540
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

176
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,...
176

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Pharmaceutical Approval Update.

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    P & T : a Peer-Reviewed Journal for Formulary Management
    |October 2, 2018
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    Summary
    This summary is machine-generated.

    New cancer and endometriosis therapies show promise. Ivosidenib (Tibsovo) treats acute myeloid leukemia, elagolix (Orilissa) addresses endometriosis, and mogamulizumab-kpkc (Poteligeo) targets specific skin cancers.

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    Area of Science:

    • Oncology
    • Hematology
    • Gynecology
    • Dermatology

    Background:

    • Acute myeloid leukemia (AML) is a challenging hematologic malignancy.
    • Endometriosis significantly impacts women's health and quality of life.
    • Mycosis fungoides and Sézary syndrome are rare T-cell lymphomas affecting the skin.

    Purpose of the Study:

    • To review the efficacy and safety of novel therapeutic agents for specific conditions.
    • Highlighting advancements in targeted cancer therapies and women's health treatments.

    Main Methods:

    • Review of clinical trial data and regulatory approvals for Ivosidenib, elagolix, and mogamulizumab-kpkc.
    • Analysis of treatment outcomes, including response rates and adverse events.

    Main Results:

    • Ivosidenib demonstrated significant efficacy in patients with IDH1-mutated AML.
    • Elagolix provided effective pain management and reduction of endometriosis-associated symptoms.
    • Mogamulizumab-kpkc showed positive responses in patients with mycosis fungoides and Sézary syndrome.

    Conclusions:

    • These agents represent important therapeutic options for their respective indications.
    • Targeted therapies are advancing treatment paradigms in oncology and women's health.
    • Further research will continue to refine the use of these novel medications.