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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.
Measurement of Bioavailability: Pharmacodynamic Methods01:20

Measurement of Bioavailability: Pharmacodynamic Methods

Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
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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...
Drug Concentrations: Measurements01:23

Drug Concentrations: Measurements

Drug concentration is the quantity of a drug present in a biological sample. Measuring drug amounts in biological samples allows the clinician to understand how a drug is absorbed, distributed, metabolized, and excreted. Samples can be obtained through invasive or non-invasive methods. Invasive techniques involve surgical or parenteral interventions to gather blood, cerebrospinal fluid, or tissue biopsy. Conversely, non-invasive approaches provide samples like urine, feces, and saliva.
Plasma —...
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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.
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Measuring US pharmaceutical industry R&D spending.

Joseph Golec1, John Vernon

  • 1Finance Department, School of Business, University of Connecticut, Storrs, Connecticut 06269-1041, USA. jgolec@business.uconn.edu

Pharmacoeconomics
|November 19, 2008
PubMed
Summary

Government policy debates on drug pricing are complicated by differing R&D spending data. This study compares National Science Foundation (NSF) and Pharmaceutical Research and Manufacturers of America (PhRMA) data, proposing a more reliable Compustat-based alternative.

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Area of Science:

  • Health economics
  • Pharmaceutical policy
  • Data science

Background:

  • Government policy debates regarding pharmaceutical pricing frequently hinge on the relationship between drug prices and company-financed research and development (R&D) spending.
  • In the United States, a significant divergence exists in these debates due to the use of disparate R&D spending measures by different stakeholders.
  • Government agencies, legislative bodies, and consumer advocacy groups typically rely on survey data from the National Science Foundation (NSF), while the pharmaceutical industry utilizes data from the Pharmaceutical Research and Manufacturers of America (PhRMA).

Purpose of the Study:

  • To critically evaluate the strengths and weaknesses of the commonly used National Science Foundation (NSF) and Pharmaceutical Research and Manufacturers of America (PhRMA) survey data series for measuring pharmaceutical R&D spending.
  • To address the discrepancies in R&D spending data that impact policy debates and academic research.
  • To introduce and validate a novel, more reliable, comprehensive, and replicable R&D spending data series derived from Compustat.

Main Methods:

  • Comparative analysis of R&D spending data from the National Science Foundation (NSF) and Pharmaceutical Research and Manufacturers of America (PhRMA) survey datasets.
  • Identification and discussion of the pros and cons inherent in each of the existing data series.
  • Development and validation of an alternative R&D spending data series using Compustat financial database information.

Main Results:

  • The study highlights significant discrepancies between NSF and PhRMA R&D spending data, contributing to the polarization of policy debates.
  • Analysis reveals limitations in both NSF and PhRMA data collection methodologies and scope.
  • The proposed Compustat-based data series demonstrates superior reliability, comprehensiveness, and replicability compared to existing measures.

Conclusions:

  • The differing metrics for R&D spending used by government bodies and the pharmaceutical industry create confusion and hinder effective policy-making on drug pricing.
  • Academic research relying on either NSF or PhRMA data may yield inconsistent findings.
  • The Compustat-based R&D spending data series offers a robust foundation for more accurate analysis and informed policy discussions concerning pharmaceutical pricing and innovation.