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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.
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,...
Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

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,...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each indication due to...

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Methods for the comparative evaluation of pharmaceuticals.

Annette Zentner1, Marcial Velasco-Garrido, Reinhard Busse

  • 1Fachgebiet Management im Gesundheitswesen, Institut für Gesundheitswissenschaften, Fakultät VIII, Technische Universität Berlin, Berlin, Deutschland.

GMS Health Technology Assessment
|February 4, 2011
PubMed
Summary
This summary is machine-generated.

Many countries evaluate pharmaceuticals for reimbursement and pricing, focusing on therapeutic benefit and patient quality of life. However, standardized methods for comparative drug assessment are still developing internationally.

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Area of Science:

  • Health Technology Assessment (HTA)
  • Pharmaceutical Policy
  • Comparative Drug Evaluation

Background:

  • The German Institute for Quality and Efficiency in Health Care (IGWiG) was established to evaluate pharmaceutical benefits.
  • A key policy objective is to base decisions on scientific assessment compared to existing treatments.
  • Procedures and methods for comparative drug assessment are still under development.

Purpose of the Study:

  • To analyze criteria, procedures, and methods for comparative drug assessment in other EU/OECD countries.
  • To understand how national public institutions compare medicines for regulation, reimbursement, and pricing.
  • To identify best practices in drug evaluation.

Main Methods:

  • Commissioned health technology assessment (HTA) report.
  • Analysis of criteria, procedures, and methods of comparative drug assessment in EU/OECD countries.
  • Systematic literature and internet searches for relevant institutions and documents.
  • Qualitative analysis using a pre-defined framework.
  • Narrative summarization and evidence tables.

Main Results:

  • Licensing agencies often lack systematic assessment of a new drug's added value.
  • Post-licensing evaluation is frequently required for reimbursement/pricing decisions.
  • Therapeutic benefit, particularly improved benefit/risk profile and quality of life, is the leading evaluation criterion.
  • Pharmacoeconomic evaluations are common, but criteria vary.
  • Randomized controlled head-to-head trials (RCTs) are preferred for evidence, but often lacking.
  • Indirect comparisons and economic modeling are used as alternatives when direct evidence is unavailable.

Conclusions:

  • Most countries base reimbursement/pricing on systematic evaluations of clinical and economic drug characteristics.
  • International standards for evaluation criteria and methodologies are still lacking.
  • Further development is needed for consistent and robust comparative drug assessment globally.