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Related Concept Videos

Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

7
Body: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...
7
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

5
Body: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...
5
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

17
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...
17
Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems01:22

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems

8
Body:Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug...
8
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

8
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
8
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

10
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Maximizing data value for biopharma through FAIR and quality implementation: FAIR plus Q.

Ian Harrow1, Rama Balakrishnan2, Hande Küçük McGinty3

  • 1Pistoia Alliance, USA.

Drug Discovery Today
|January 23, 2022
PubMed
Summary
This summary is machine-generated.

Academia and industry are collaborating to make life sciences data Findable, Accessible, Interoperable, and Reusable (FAIR). Implementing FAIR principles enhances data quality and value for developing new medical treatments.

Keywords:
Data quality assessmentData-centric cultureFAIR dataFAIR maturity indicatorsFAIR use cases

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Area of Science:

  • Life Sciences
  • Biopharmaceutical Research
  • Data Science

Background:

  • Growing collaboration between academia and industry in life sciences.
  • Increasing focus on making research data Findable, Accessible, Interoperable, and Reusable (FAIR).
  • The transition to a data-centric approach is ongoing.

Purpose of the Study:

  • To review use cases for implementing FAIR principles in life sciences.
  • To explore how FAIR data enhances the value of research, clinical, and real-world healthcare data.
  • To support the discovery and development of new medical treatments.

Main Methods:

  • Literature review of FAIR implementation strategies.
  • Analysis of use cases across research, clinical trials, and real-world healthcare data.
  • Discussion of data quality assessment in conjunction with FAIR principles.

Main Results:

  • FAIR implementation offers significant value when combined with data quality assessment.
  • Use cases demonstrate the utility of FAIR data in biopharmaceutical research.
  • The shift to data-centricity is a continuous process requiring ongoing effort.

Conclusions:

  • FAIR data principles are crucial for maximizing the value of life sciences data.
  • Effective implementation of FAIR data accelerates the development of novel medical treatments.
  • Continued collaboration and focus on FAIR are essential for future advancements.