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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...
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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.
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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.
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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...
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MicroRNAs01:22

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MicroRNA (miRNA) are short, regulatory RNA transcribed from introns—non-coding regions of a gene—or intergenic regions—stretches of DNA present between genes. Several processing steps are required to form biologically active, mature miRNA. The initial transcript, called primary miRNA (pri-mRNA), base-pairs with itself forming a stem-loop structure. Within the nucleus, an endonuclease enzyme, called Drosha, shortens the stem-loop structure into hairpin-shaped pre-miRNA. After...
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Related Experiment Video

Updated: Nov 30, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
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Europe PMC in 2020.

Christine Ferguson1, Dayane Araújo1, Lynne Faulk1

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

Nucleic Acids Research
|November 12, 2020
PubMed
Summary
This summary is machine-generated.

Europe PMC now integrates life science preprints and COVID-19 research, enhancing access to biomedical information. The database offers expanded content links and an improved user interface for researchers.

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Area of Science:

  • Biomedical Informatics
  • Life Sciences Data Aggregation
  • Scientific Publishing

Background:

  • Europe PMC serves as a comprehensive repository for biomedical research articles and abstracts.
  • Recent advancements focus on expanding content and improving user accessibility.

Purpose of the Study:

  • To detail recent developments and new features implemented in Europe PMC since 2017.
  • To highlight Europe PMC's unique position as an aggregator of both peer-reviewed articles and preprints.
  • To showcase improvements in content discoverability and user experience.

Main Methods:

  • Integration of life science preprint abstracts and a dedicated collection of COVID-19 preprints.
  • Expansion of links to related content, including Unpaywall, preprint peer-review platforms, and data resources.
  • Redesign of the Europe PMC website with merged article views and enhanced navigation.
  • Enhancement of the annotations platform with text-mined biological terms.

Main Results:

  • Europe PMC now offers over 180,000 preprints alongside peer-reviewed articles.
  • Expanded links provide wider access to full-text articles, peer-review information, and curated data.
  • The redesigned website offers a more user-friendly experience with integrated article views and improved navigation.
  • The annotations platform provides access to approximately 1.3 billion text-mined biological terms.

Conclusions:

  • Europe PMC has significantly enhanced its offerings, becoming a more valuable resource for life scientists.
  • The platform's unique aggregation of preprints and peer-reviewed articles, coupled with improved accessibility and navigation, supports research discovery.
  • The expanded annotations platform further enriches the resource by providing extensive biological term data.