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Regulatory Data Articles & Analysis

5 articles found

The Importance of Data Diversity to Enhance Clinical Trials Success

The Importance of Data Diversity to Enhance Clinical Trials Success

Medical advancement relies on clinical trials, which are essential for the development of safe and effective innovative treatments. However, the success and general applicability of these treatments heavily depend on the diversity of the participants involved¹?³. This blog explores the importance of achieving data diversity in clinical trials to enhance clinical trial results and ...

BySOPHiA Genetics


Targeted Region Sequencing in Human Disease Studies and Clinical Care

Targeted Region Sequencing in Human Disease Studies and Clinical Care

With the ability to rapidly produce large volumes of sequencing data, next-generation sequencing (NGS) enables researchers to obtain whole genome or targeted regions of samples. ...

ByCD Genomics


Avoiding Regulatory shortfalls in the Submission Path

Avoiding Regulatory shortfalls in the Submission Path

This is the area where many of the bio-pharma, consumer healthcare, medical device manufacturers, R&D department, CROs and regulatory agencies face challenges. All companies need clear guidelines on when, how, and at which stage they have need regulatory submissions. ...

ByDDi LLC


Managing emissions of active pharmaceutical ingredients from manufacturing facilities: An environmental quality standard approach

Managing emissions of active pharmaceutical ingredients from manufacturing facilities: An environmental quality standard approach

Building on these concepts, the approach takes into account indirect exposure of potential consumers such as fish‐eating mammals and humans, as well as primary producers (e.g., algae) and primary and secondary consumers (e.g., invertebrates and fish). Although chronic toxicity data are preferred for ERC derivation, acute data, with appropriate considerations of ...

ByJohn Wiley & Sons, Ltd.


Environmental Profile of the Pharmaceutical Industry

These notebooks, which focus on key indicators that holistically present air, water, and land pollutant release data, have been thoroughly reviewed by experts from both inside and outside the EPA. ...

ByUS EPA - Environmental Protection Agency

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