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Related Concept Videos

Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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...
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.
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Production of Pharmaceuticals01:30

Production of Pharmaceuticals

Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under sterile, tightly...

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Europe PMC in 2023.

Summer Rosonovski1, Maria Levchenko1, Rajat Bhatnagar1

  • 1Literature Services, EMBL-EBI, Wellcome Trust Genome Campus, Cambridge, UK.

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Summary
This summary is machine-generated.

Europe PMC enhances its open access database for life sciences with improved preprint discoverability, text and data mining support, and new user notification tools. These updates aim to boost research reproducibility and accessibility.

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Area of Science:

  • Life Sciences
  • Bioinformatics
  • Scholarly Communication

Background:

  • Europe PMC is a major open access database for life science literature.
  • The platform provides access to over 42 million abstracts and 9 million full-text articles.
  • Previous platform developments were last updated in 2020.

Purpose of the Study:

  • To outline recent advancements in the Europe PMC platform since 2020.
  • To detail improvements in preprint handling, text and data mining capabilities, and user services.
  • To position Europe PMC as a sustainable, accessible, and open scholarly infrastructure.

Main Methods:

  • Indexing new preprint content and enriching metadata.
  • Expanding annotation types and developing the Europe PMC Annotations Corpus for machine learning.
  • Implementing the Article Status Monitor tool and email alerts.
  • Increasing open-source software components and enhancing service sustainability.

Main Results:

  • Improved discoverability, reproducibility, and trust in preprints through enhanced indexing and metadata.
  • Enhanced support for text and data mining with expanded annotations and a dedicated corpus.
  • New tools for users to monitor articles and receive updates.
  • Progress towards a more open, sustainable, and accessible scholarly infrastructure.

Conclusions:

  • The recent developments significantly enhance the Europe PMC platform's utility for researchers.
  • These updates strengthen Europe PMC's role in supporting open science and reproducible research.
  • The platform is better positioned to serve the evolving needs of the life science community.