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Related Concept Videos

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,...
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.
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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...
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,...
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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Updated: May 30, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Curricular considerations for pharmaceutical comparative effectiveness research.

Michael D Murray1

  • 1Purdue University College of Pharmacy and Regenstrief Institute, Indianapolis, IN 46202, USA. mmurray@regenstrief.org

Pharmacoepidemiology and Drug Safety
|July 29, 2011
PubMed
Summary
This summary is machine-generated.

Federal funding for comparative effectiveness research (CER) necessitates trained scientists. Pharmacoepidemiologists possess key skills for CER curriculum development, particularly in pharmaceutical sciences.

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Area of Science:

  • Health Sciences
  • Pharmaceutical Sciences
  • Health Policy

Background:

  • U.S. congressional appropriation of $1.1 billion for comparative effectiveness research (CER) creates a demand for trained professionals.
  • The need for skilled scientists and decision-makers in CER research and implementation is a direct consequence of this funding.
  • An expert panel, primarily from pharmaceutical fields, was convened to define curriculum requirements for CER in health professions, focusing on pharmaceuticals.

Purpose of the Study:

  • To identify essential knowledge, skills, and abilities for developing a CER curriculum for health professions.
  • To assess the role of pharmacoepidemiology in training for CER, especially concerning pharmaceuticals.
  • To address the need for trained personnel to support the growing field of CER.

Main Methods:

  • Convening an interdisciplinary expert panel with a predominant pharmaceutical focus.
  • Examining knowledge, skills, and abilities relevant to CER curriculum development.
  • Acknowledging panel composition limitations regarding the full scope of CER (devices, services, diagnostics, etc.).

Main Results:

  • Key curriculum components identified include study design and data source evaluation.
  • Essential skills encompass confounding/bias control methods, data management, and clinical insight.
  • Most identified competencies align with existing pharmacoepidemiology training.

Conclusions:

  • Pharmacoepidemiologists are well-suited to contribute significantly to CER training programs.
  • Despite CER's broader scope, pharmacoepidemiology offers valuable expertise, particularly in pharmaceutical sciences.
  • Pharmacoepidemiologists should play a central role in designing and delivering CER training curricula.