Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Improving Translational Accuracy02:07

Improving Translational Accuracy

Base complementarity between the three base pairs of mRNA codon and the tRNA anticodon is not a failsafe mechanism. Inaccuracies can range from a single mismatch to no correct base pairing at all. The free energy difference between the correct and nearly correct base pairs can be as small as 3 kcal/ mol. With complementarity being the only proofreading step, the estimated error frequency would be one wrong amino acid in every 100 amino acids incorporated. However, error frequencies observed in...
Improving Translational Accuracy02:07

Improving Translational Accuracy

Base complementarity between the three base pairs of mRNA codon and the tRNA anticodon is not a failsafe mechanism. Inaccuracies can range from a single mismatch to no correct base pairing at all. The free energy difference between the correct and nearly correct base pairs can be as small as 3 kcal/ mol. With complementarity being the only proofreading step, the estimated error frequency would be one wrong amino acid in every 100 amino acids incorporated. However, error frequencies observed in...
Drug Product Performance: In Vitro–In Vivo Correlation01:20

Drug Product Performance: In Vitro–In Vivo Correlation

In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while adhering...
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...
Leaky Scanning02:28

Leaky Scanning

During most eukaryotic translation processes, the small 40S ribosome subunit scans an mRNA from its 5' end until it encounters the first start AUG codon. The large 60S ribosomal subunit then joins the smaller one to initiate protein synthesis. The location of the translation initiation is largely determined by the nucleotides near the start codon as there may be multiple translation initiation sites present on the mRNA.  Marilyn Kozak discovered that the sequence RCCAUGG (where R stands for...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Longitudinal Non-interventional Changes of the FORTA Score are Associated with Changes of Cognitive and Physical Function Tests in Community-Dwelling Older People.

Drugs & aging·2026
Same author

Editorial: Optimizing medication management in older adults: addressing polypharmacy, deprescribing and represcribing challenges.

Frontiers in medicine·2026
Same author

[Why represcribing instead of deprescribing?]

Innere Medizin (Heidelberg, Germany)·2026
Same author

Evaluating the translational value of preclinical models: Available tools and frameworks, challenges and strategies.

Alternatives to laboratory animals : ATLA·2025
Same author

The FORTA (Fit for the Aged) List 2024: Fifth Version of a Validated Clinical Aid for Improved Pharmacotherapy in Older Adults.

Drugs & aging·2025
Same author

SURGE-ahead postoperative delirium prediction: external validation and open-source library.

European geriatric medicine·2025

Related Experiment Video

Updated: May 24, 2026

Cost-Efficient Transcriptomic-Based Drug Screening
06:40

Cost-Efficient Transcriptomic-Based Drug Screening

Published on: February 23, 2024

Translatability scoring in drug development: eight case studies.

Alexandra Wendler1, Martin Wehling

  • 1Institute of Experimental and Clinical Pharmacology and Toxicology Clinical Pharmacology Mannheim, Faculty of Medicine Mannheim, Ruprecht-Karls-University of Heidelberg, Maybachstr,14, D-68169 Mannheim, Germany.

Journal of Translational Medicine
|March 9, 2012
PubMed
Summary
This summary is machine-generated.

A new scoring system helps predict drug development success by evaluating early-stage projects. High-quality biomarkers are crucial for reducing translational risk and increasing market approvals.

Related Experiment Videos

Last Updated: May 24, 2026

Cost-Efficient Transcriptomic-Based Drug Screening
06:40

Cost-Efficient Transcriptomic-Based Drug Screening

Published on: February 23, 2024

Area of Science:

  • Biomedical research
  • Drug discovery and development
  • Translational medicine

Background:

  • Translational medicine aims to translate basic research into clinical applications.
  • Low market approval rates for new drugs necessitate improved risk prediction strategies to reduce costs and increase efficiency.
  • A novel scoring system has been proposed to assess the translatability of early-stage drug projects.

Purpose of the Study:

  • To retrospectively evaluate a proposed scoring system for drug translatability.
  • To assess the system's utility in predicting the success of drug development projects.
  • To identify key factors influencing drug translatability and market approval.

Main Methods:

  • A retrospective analysis of eight drugs across various therapeutic areas was conducted.
  • The proposed scoring system was applied fictively at the phase II-III transition stage.
  • Translatability scores were correlated with actual market approval outcomes.

Main Results:

  • The scoring system highlighted the critical role of biomarker quality in reducing project risk.
  • Gefitinib demonstrated a significant increase in translatability score due to the EGFR mutation status biomarker.
  • Low scores for psychiatric, Alzheimer's, and CETP-inhibitor drugs correlated with high translational risks, often due to a lack of suitable biomarkers and animal models.

Conclusions:

  • The scoring system shows potential utility in retrospectively assessing drug development translatability.
  • Biomarker quality is a pivotal factor in de-risking drug development projects.
  • While prospective validation is pending, retrospective case studies suggest the scoring system's encouraging correlation with market approval outcomes.