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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

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Pharmaceutical approval update.

Marvin M Goldenberg

    P & T : a Peer-Reviewed Journal for Formulary Management
    |September 20, 2013
    PubMed
    Summary
    This summary is machine-generated.

    New inhaled medications for COPD, cholesterol-lowering tablets, and radium injections for prostate cancer are reviewed. These treatments offer options for managing chronic diseases and late-stage cancer.

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    Published on: December 17, 2021

    Area of Science:

    • Pharmacology and Therapeutics
    • Oncology
    • Pulmonology
    • Cardiology

    Background:

    • Chronic obstructive pulmonary disease (COPD) requires effective long-term management strategies.
    • Hyperlipidemia, particularly elevated low-density lipoprotein cholesterol (LDL-C), is a significant cardiovascular risk factor.
    • Advanced, castration-resistant prostate cancer presents therapeutic challenges, necessitating novel treatment approaches.

    Purpose of the Study:

    • To review the efficacy and safety of fluticasone furoate/vilanterol (Breo Ellipta) for COPD management.
    • To evaluate the effectiveness of atorvastatin/ezetimibe (Liptruzet) in reducing LDL-C levels.
    • To assess the role of radium 223 dichloride (Xofigo) in treating late-stage, castration-resistant prostate cancer.

    Main Methods:

    • Review of clinical trial data and pharmacologic profiles for fluticasone furoate/vilanterol.
    • Analysis of studies investigating the lipid-lowering effects of atorvastatin/ezetimibe combination therapy.
    • Examination of outcomes from trials involving radium 223 dichloride in prostate cancer patients.

    Main Results:

    • Fluticasone furoate/vilanterol demonstrates benefits in improving lung function and reducing exacerbations in COPD patients.
    • Atorvastatin/ezetimibe provides significant reductions in LDL-C compared to monotherapy.
    • Radium 223 dichloride has shown survival benefits and symptomatic improvement in men with metastatic castration-resistant prostate cancer.

    Conclusions:

    • Combination inhaled therapy with fluticasone furoate/vilanterol is a valuable option for COPD.
    • Atorvastatin/ezetimibe is an effective treatment for hyperlipidemia, contributing to cardiovascular risk reduction.
    • Radium 223 dichloride represents a targeted therapeutic advance for advanced prostate cancer.