JAMA Internal Medicine

JANUARY 22, 2023

This randomized clinical trial determines contamination rates after high-level disinfection and technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Dr. Bahassi: There are several factors to consider when designing a trial that involves ctDNA detection.

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Bio Pharma Dive

DECEMBER 22, 2021

The FDA has halted all clinical trials testing the injectable form of Gilead's lenacapavir, for fear that incompatibility between the drug and the vials it's held in could cause contamination.

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Imperical Blog

OCTOBER 22, 2020

Health Care and Trials in the Age of COVID-19. Some patients have had clinical trials halt, or even postponed indefinitely, and for far too many patients, especially cancer patients, those clinical trials might well have been a lifeline. CROs Leading Decentralized Trials. Balance, it seems, for some.

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Imperical Blog

OCTOBER 22, 2020

Health Care and Trials in the Age of COVID-19. Some patients have had clinical trials halt, or even postponed indefinitely, and for far too many patients, especially cancer patients, those clinical trials might well have been a lifeline. CROs Leading Decentralized Trials. Balance, it seems, for some.

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Clinical Trials Clinical Trials Trials Nurses 52

Drug Discovery Today

APRIL 21, 2020

Panthera’s second clinical trial site in the UK, in North Manchester is open for business.As a standalone site ideal for existing or new trials with much lower contamination risk during COVID-19

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Clinical Trials Clinical Trials Contamination Trials 40

Drug Discovery World

MAY 19, 2023

This week we have reported on the launch of a number of new Phase I trials in a range of disease areas. In-human studies have been initiated to test treatments for Parkinson’s disease, radioactive contamination, Dravet Syndrome, influenza and inflammatory diseases.

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Contamination Clinical Trials Clinical Trials Drugs 52

Drug Discovery World

MAY 22, 2023

It was recently Clinical Trials Day and DDW have reported on the launch of a number of new Phase I trials. In-human studies have been initiated to test treatments for Parkinson’s disease, radioactive contamination, Dravet Syndrome, influenza and inflammatory diseases.

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Contamination Clinical Trials Clinical Trials Trials 52

pharmaphorum

MARCH 19, 2021

DeepVerge has announced trial data showing its COVID-19 Microtox BT breath test can deliver accurate results in under 60 seconds, with a potential roll-out later this year if further tests support it. A large clinical trial is ongoing in Dubai. A femtogram is 0.000000000000000001 kilograms.

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Contamination Clinical Trials Clinical Trials Protein 145

Drug Discovery World

MAY 22, 2023

It was recently Clinical Trials Day and DDW have reported on the launch of a number of new Phase I trials. In-human studies have been initiated to test treatments for Parkinson’s disease, radioactive contamination, Dravet Syndrome, influenza and inflammatory diseases.

Contamination 52

Contamination Clinical Trials Clinical Trials Trials 52

Sciensano

MARCH 27, 2024

Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. Although several health authorities warned the public against using this medicine outside clinical trials, the medicine was widely used on a major scale in late 2020 and in 2021.

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Contamination Bacteria Packaging Packaging 52

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Clinical Research Compliance Research Regulation 52

JAMA Internal Medicine

MARCH 7, 2021

Yet, these summed findings obscure the inconsistent results of individual clinical trials, which have raised uncertainty and controversy about health benefits. In addition, associated behaviors of individuals who eat fish (eg, other dietary factors and socioeconomic status) could overestimate benefits in observational studies.

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Contamination Clinical Trials Clinical Trials Containment 49

XTalks

JANUARY 4, 2023

We appreciate and thank the burn patients who participated in our trials, the clinical investigators and our researchers for their commitment and efforts to attain this significant achievement.”. “We Clinical Trials of NexoBrid.

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FDA Approval Clinical Trials Clinical Trials Contamination 98

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Find Me Cure

MARCH 13, 2020

Second to respiratory droplets (someone coughing or sneezing less than 6 feet away from you), touching contaminated surfaces is the fastest way to spread the virus. . In fact, there are as many as 16 clinical trials already available on our platform ranging in purpose from observation to prevention to treatment.

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Clinical Trials Clinical Trials Doctors Doctor 98

XTalks

JULY 25, 2023

While there is no evidence of person-to-person transmission, anthrax skin lesions may be contagious through direct contact or contaminated objects. The bacteria usually enter the body through wounds, but infection can also occur through contaminated meat or inhalation of spores. Additionally, at Day 64, 86.6

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FDA Approval Vaccination Vaccine Antibody 98

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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The Pharma Data

DECEMBER 30, 2020

Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart. Using the contaminated mouthwash can result in “oral and, potentially, systemic infections requiring antibacterial therapy.

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Contamination Vaccination Vaccine Pharmacy 52

Pharmaceutical Technology

JULY 22, 2022

Peter Hotez’s tweet on PAI Life Sciences’ phase 1 trial of its snail fever vaccine. The phase 1 clinical trial will evaluate the safety and immune response of the vaccine in healthy individuals at the Kaiser Permanente Washington Health Research Institute in Seattle, the article detailed.

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Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies.

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Engineer Genetics Clinical Research Research 52

Olympian Clinical Research

SEPTEMBER 22, 2022

Fungal nail infections may also spread through contact with contaminated surfaces, such as public showers, pool decks, or locker room floors. Participate in a Clinical Trial on Toenail Fungus at Olympian Clinical Research. In addition, sharing a toenail clipper with someone who has an infection may put you at risk.

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Clinical Research Clinical Trials Clinical Trials Contamination 52

XTalks

SEPTEMBER 12, 2022

Related: What are Food Clinical Trials and What Purpose do They Serve? In June, the FDA updated its action levels for lead in baby food and indicated that it would update its action levels for other heavy metal contaminants in the years that follow. Labeling Clarity on Lab-Grown Meat.

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Cloudbyz

NOVEMBER 9, 2021

If you find out a sample was contaminated at the source, you can alert all relevant personnel within a matter of seconds before confirming they all received the alert in person. Automated alerts can prevent potential major disruptions and control the damage for present ones. Easier Data Matching. Timely eConsent.

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Biobanking Contamination Life Science Packaging 80

The Pharma Data

AUGUST 21, 2020

Regeneron claims REGN-COV2, which is currently being studied in two Phase 2/3 clinical trials, provides a much-needed treatment option for Covid-19 that has the potential to prevent infection and thus slow down the spread of the pandemic on a global scale. Sign up now.

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Vaccination Vaccine Manufacturing Contamination 52

Rethinking Clinical Trials

NOVEMBER 6, 2023

Cook, PhD Senior Biostatistics Investigator, Kaiser Permanente Washington Health Research Institute Slides Keywords Individually randomized group treatments; Intervention; Randomization; Clinical trials Key Points In individually randomized trials (IRTs), individuals are randomized to either control or intervention arms.

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Trials Clinical Trials Clinical Trials Contamination 130

The Pharma Data

DECEMBER 28, 2020

With no protruding parts and recessed nozzle and shutter, Optejet’s design enables touch-free mydriasis and helps reduce the risk of cross contamination.”. The NDA submission was based on the MIST-1 and MIST-2 studies. In these two Phase 3 studies, a fixed combination of micro-dosed phenylephrine 2.5%

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Drugs Production Marketing Contamination 52

XTalks

FEBRUARY 8, 2024

In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing. The efficacy and safety of Rybelsus in reducing blood sugar in patients with type 2 diabetes were investigated in various clinical trials. billion ($657 million). billion in 2022.

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Sales Insulin FDA Approval Drugs 52

Camargo

AUGUST 5, 2021

Prograf was originally approved in 1994 to prevent organ rejection in patients receiving liver transplants, based on the traditional two randomized, open-label, active control trials. In short, the entire regulatory history of tacrolimus until now, spanning 25+ years, has been based on prospective clinical trials.

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Druggist

SEPTEMBER 15, 2020

cm FAST HEALING: ultra-thin hydrocolloid gel provides a moist environment to help reduce scab formation REDUCES CONTAMINATION AND WORSENING: protective barrier against external environment STAYS IN PLACE UP TO 12 HOURS: adhesive, tapered edges so Compeed flexes with movement £6.99 −£1.74 £5.25 Buy on Amazon Price incl.

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XTalks

AUGUST 7, 2023

He also thanked the 500 patients, caregivers, investigators and healthcare professionals involved in the Phase III trials and stated that Verrica’s commercial team is actively preparing for the product’s commercial launch in September 2023. Participants in these trials ranged in age from two to 60, with a median age of six.

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Drug Discovery World

AUGUST 16, 2022

These observations may come to light in the clinic, but these disparities can be attributed to every phase of the drug development pipeline – clinical trials, translational research and, ultimately, drug discovery. . Cancer risks also increase in areas with water contaminants or polluted air.

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The Pharma Data

JANUARY 27, 2021

Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

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Clinical Trials Clinical Trials Production Trials 52

Camargo

NOVEMBER 29, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.

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XTalks

MAY 30, 2023

Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments. There are also several ECG patches currently in clinical trials that could soon enter the market.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

pharmaphorum

JUNE 28, 2022

The first attempt was turned down by the FDA over concerns about with the drug’s manufacturing, specifically issued related to the possibility of “sub-visible” particulate contamination from the borosilicate glass vials that were originally used to produce the drug.

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Olympian Clinical Research

JANUARY 27, 2021

You worry about contamination and catching/spreading germs. At Olympian Clinical Research we understand just how seriously the symptoms of OCD can impact every aspect of patients’ lives, and our team is committed to helping OCD patients find ways to effectively manage their symptoms long term and improve their quality of life.

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Clinical Trials Clinical Trials Clinical Research Trials 52