Drug Target Review

NOVEMBER 24, 2023

Dr Jeff Lichtman, Jeremy R Knowles Professor of Molecular and Cellular Biology at Harvard University, has pioneered a field known as ‘connectomics’, creating maps of the brain in an attempt to understand this organ that has nearly 100 billion neurons communicating across trillions of synapses.

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Perficient: Drug Development

JANUARY 19, 2024

One use case organizations can consider is Synthetic Data and Document Generation, which allows companies to automate the creation of synthetic (or fake) data for testing purposes, therefore accelerating their digital transformation initiatives. What Is Synthetic Data and Document Generation?

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Advarra

JULY 18, 2022

Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. Introduction to Required Research Documents and Regulatory Compliance. In short, GCP dictates what data and documents need to be collected, stored, and audit-ready.

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BioPharma Drive: Drug Pricing

SEPTEMBER 1, 2023

The newly posted documents show the agency had concerns about the side effects experienced by people with clinical depression who took Sage’s drug, Zurzuvae.

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FDA Drugs 64

Agency IQ

JANUARY 4, 2024

In a long-anticipated draft report, the FDA has offered a vision for a series of potential improvements to the way it currently publishes guidance documents.

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FDA Regulations 59

Science Daily: Pharmacology News

FEBRUARY 8, 2024

Researchers have uncovered the first direct evidence that the West Antarctic Ice Sheet shrunk suddenly and dramatically at the end of the Last Ice Age, around eight thousand years ago.

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Research 140

Science Daily: Pharmacology News

OCTOBER 21, 2024

Scientists have discovered the earliest evidence of animal butchery by humans in India.

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Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. What has the MDCG published recently?

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BioPharma Drive: Drug Pricing

SEPTEMBER 25, 2023

Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.

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Agency IQ

JANUARY 4, 2024

In new report, FDA sketches out ideas for improving how it publishes guidance documents In a long-anticipated draft report, the FDA has offered a vision for a series of potential improvements to the way it currently publishes guidance documents. For the FDA, guidance documents come in a variety of different forms and formats.

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Agency IQ

AUGUST 4, 2023

New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U. The Windsor Framework is a political agreement between the European Commission and the U.K. government to ensure that, in the wake of Brexit, Northern Ireland continues to receive critical supplies such as food and medicines.

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The Pharma Data

MARCH 5, 2021

Securities and Exchange Commission (SEC) and its “ Document d’Enregistrement Universel ” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers ( AMF ). These documents are available on the company’s website: [link]. Source link:[link].

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Science Daily: Pharmacology News

JANUARY 5, 2024

Researchers have identified microstructures in fossil cells that are 1.75 billion years old. These structures, called thylakoid membranes, are the oldest ever discovered. They push back the fossil record of thylakoids by 1.2

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Research 88

Science Daily: Pharmacology News

NOVEMBER 20, 2024

For the first time, Ethiopian wolves have been documented feeding on the nectar of Ethiopian red hot poker flowers. This is the first large carnivore species ever to be documented feeding on nectar. In doing so, the wolves may act as pollinators -- perhaps the first known plant-pollinator interaction involving a large carnivore.

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Drug Patent Watch

MARCH 25, 2020

The post Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average appeared first on DrugPatentWatch - Make Better Decisions. This article was originally published by Hermann Mucke & Peter Mucke in Future Drug Discovery under a Attribution-NonCommercial-NoDerivatives 4.0

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Licensing Licensing Drugs Drug Development 53

Science Daily: Pharmacology News

OCTOBER 1, 2024

A new study documents how Southern Californians are chronically being exposed to toxic airborne chemicals called plasticizers, including one that's been banned from children's items and beauty products.

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thought leadership

SEPTEMBER 30, 2024

However, do you really know what a CER is and how it evolved into the modern document required for the EU MDR (Medical Device Regulation)? In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER).

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Advarra

AUGUST 21, 2024

These complex studies typically generate hundreds or thousands of documents to share across clinical trial sites, pharmaceutical sponsors, physicians, patients, and regulators. Everyone may use different software systems to manage these documents. Nowhere is this more painful than in clinical trials, the backbone of drug development.

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Agency IQ

AUGUST 4, 2023

New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., The document specifically notes that it applies to “medicinal products for human use intended to be placed on the market in Northern Ireland in accordance with Article 6 of Directive 2001/83/EC,” the current European pharmaceutical legislation.

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Science Daily: Pharmacology News

AUGUST 13, 2024

A new interpretation of the runic inscription on the Forsa Ring (Forsaringen in Swedish), provides fresh insights into the Viking Age monetary system and represents the oldest documented value record in Scandinavia. The inscription describes how the Vikings handled fines in a flexible and practical manner.

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FDA Law Blog: Biosimilars

DECEMBER 2, 2024

We have seen this come up in many device reviews over the last several years, so we are not surprised to see it make its way to the draft guidance, but the justification for this burdensome approach is not provided and having conflicting recommendations in two related documents (i.e.,

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Science Daily: Pharmacology News

MAY 29, 2024

According to a recent study, dogs trained to detect scent may be able to identify significantly lower concentrations of odour molecules than has previously been documented.

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Broad Institute

OCTOBER 2, 2024

Documentation for the GTEx API Documentation for the Get Gene Expression web service First example API call Documentation for the Get Genes web service Get Genes API call Example Get Gene Expression API call filtered by tissue For more information visit: [link].

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Science Daily: Pharmacology News

AUGUST 12, 2024

New findings document fewer ship tracks, reduced cloud cover, and boosted warming after ship emissions regulations took effect in 2020.

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Regulations 108

Quanticate

MARCH 5, 2024

The integrated summary of safety (ISS) and integrated summary of effectiveness (ISE) are critical documents required for regulatory submissions in the approval of new medicines/drugs or devices. What is an ISS and an ISE?

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Clinical Trials Production Trials Drugs 98

Science Daily: Pharmacology News

JULY 10, 2024

A record-breaking swim by two lion brothers across a predator-infested African river has been documented in a new study. The researchers say the 1km swim is another example of iconic wildlife species having to make tough decisions to find homes and mates in a human-dominated world.

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Research 108

Science Daily: Pharmacology News

OCTOBER 17, 2024

Researchers report on their creation of a catalog of genes that viruses 'stole' from the marine microbes they infected across all of the world's oceans, identifying and organizing almost 23,000 genes known as auxiliary metabolic genes (AMGs), including over 7,000 never previously documented.

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Virus Research 88

Science Daily: Pharmacology News

NOVEMBER 9, 2023

A new study documents how Greenland's peripheral glaciers have changed from 1890 to 2022. Using satellite images and a unique archive of historical aerial photos, researchers documented changes in the lengths of more than 1,000 of the country's glaciers over the past 130 years.

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Science Daily: Pharmacology News

OCTOBER 24, 2024

A historical supernova documented by Chinese and Japanese astronomers in 1181 has been lost for centuries, until very recently. Yet, the newly found remnant shows some stunning characteristics that are puzzling astronomers. Now, it surrenders its secrets.

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Perficient: Drug Development

OCTOBER 9, 2024

Accessibility considerations can impact several portions of the FDA submission process, including: Software Documentation : The FDA requires detailed documentation of the software development process, including usability testing.

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Compliance Engineering FDA Production 52

Quanticate

SEPTEMBER 2, 2024

One document which plays an essential role in the safety, traceability and overall validity of a clinical trial is the Statistical Analysis Plan (SAP). As a result, clinical trials must be performed to the highest degree of scientific and ethical standards, for results to be recognised as credible and the trial deemed as successful.

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Clinical Trials Trials Clinical Research Production 52

Perficient: Drug Development

JUNE 25, 2024

Apache PDFBox is a versatile open-source library designed to work with PDF documents. It is widely used in various Java applications to create, modify, extract, and print PDF documents. Key Features of PDFBox PDF Creation PDFBox allows developers to create new PDF documents programmatically.

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SCIENMAG: Medicine & Health

JANUARY 11, 2024

The effects of aging and external factors like UV exposure on skin are well documented. As people age or spend more time in the sun, their skin tends to become drier and more wrinkled, Credit: University of California San Diego The effects of aging and external factors like UV exposure on skin are well documented. […]

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Research 86

Agency IQ

JULY 26, 2024

BY AMANDA CONTI FDA has fulfilled its commitment under the Over-the-Counter Monograph Drug User Fee (OMUFA) program to issue final guidance on how sponsors can electronically submit monographs and other documents. The final document reflects the agency’s efforts to develop reference guides for its upload portals.

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Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 2024 -- Scientists have documented the first case of Down syndrome in Neanderthals, a finding which also supports the notion that these cousins of modern man were capable of providing care and support to a vulnerable member of.

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Perficient: Drug Development

OCTOBER 25, 2024

It is important to note that a roadmap is an evolving document. Source: Facebook Insights from MITcon 2018 Source: Sample Agile Roadmap Template from Business Documents Why Use a Product Roadmap? What matters most is maintaining the document as a living reference, helping to guide and align the organization.

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Production 52

Cytel

MAY 16, 2024

This addition is crucial, as documentation is a serious and important aspect of our industry. Each of us must contribute to this documentation effort and stick to the principle “if it is not documented, it did not happen.”

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Trials 59