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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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.
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,...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

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

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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...
Time Course of Drug Effect01:14

Time Course of Drug Effect

The progression of a drug's impact can be analyzed by examining both the concentration-time course and the effect-time course. The concentration-time course is determined by the drug's half-life and is influenced by factors such as its pharmacokinetics, including absorption, distribution, metabolism, and elimination. The effect of the drug is often related to its concentration in the plasma and is calculated using the maximum drug effect and the plasma concentration that generates 50 percent of...
Bioequivalence: Overview01:16

Bioequivalence: Overview

Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...

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Alefacept: where it stands today.

Jinan Chaarani1, Mark Lebwohl

  • 1Department of Dermatology, Mount Sinai School of Medicine, 5 East 98th Street, NY 10029, USA.

Expert Opinion on Drug Metabolism & Toxicology
|February 19, 2010
PubMed
Summary
This summary is machine-generated.

Alefacept is a safe biologic for treating psoriasis by targeting memory T cells. While effective for a subset of patients, its low prescription rate is due to limited efficacy, despite long-lasting effects.

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Area of Science:

  • Immunology
  • Dermatology
  • Pharmacology

Background:

  • Biologics targeting specific immune cells are emerging for immune-mediated diseases.
  • Alefacept, a biologic for psoriasis, selectively reduces CD45RO(+) memory T cells and inhibits T-cell activation.
  • Clinical data indicate alefacept's safety and efficacy in a significant patient group.

Purpose of the Study:

  • To review alefacept's mechanism of action, pharmacokinetics, and pharmacodynamics.
  • To present data on alefacept's effectiveness, treatment modes, and safety in dermatologic disorders.
  • To provide an overview of alefacept's clinical and adverse effects in psoriasis and other immune disorders.

Main Methods:

  • Literature review of alefacept's properties and clinical data.
  • Analysis of pharmacokinetic and pharmacodynamic data.
  • Evaluation of safety and efficacy studies in immune-based dermatologic conditions.

Main Results:

  • Alefacept demonstrates a favorable safety profile for psoriasis treatment.
  • Published data cover clinical effects and adverse events in various immune-based disorders.
  • Effectiveness is observed in a subset of patients, with long-lasting benefits.

Conclusions:

  • Alefacept is a safe treatment option for psoriasis.
  • Its limited efficacy in a small proportion of patients contributes to low prescription rates.
  • Tolerability and sustained effects make it suitable for responsive individuals.