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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ACRP blog

SEPTEMBER 11, 2023

Overview Decentralized clinical trials (DCTs) represent the shift towards implementing virtual research studies using digital health tools to gather data and monitor patient activity. During the COVID-19 pandemic, the clinical industry experienced significant disruption to traditional practices. This is a sponsored message.

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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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Cloudbyz

APRIL 9, 2023

Clinical trial management involves various activities and processes that can have a significant impact on the environment and contribute to sustainability issues. Clinical trials, in particular, have a significant impact on the environment, and it is essential to address this impact to ensure a sustainable future.

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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

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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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 100

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

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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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

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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FDA Approval Dermatology Trials Clinical Trials 98

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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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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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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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 45

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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Vaccine Vaccination Life Science Immune Response 130

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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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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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

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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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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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 Vaccine Vaccination Pharmacy 52

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

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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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

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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Vaccine Vaccination Manufacturing Contamination 52

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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The Pharma Data

NOVEMBER 15, 2020

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 40

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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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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Roots Analysis

SEPTEMBER 18, 2023

Cell-freezing bag failure during the prolonged storage of cellular product is likely to result in contamination of contents, which could then spread to other items kept in the same liquid nitrogen tank. As a result, during cryopreservation processing and storage, cryomacs bags become fragile and prone to cracking.

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Pharmacy Checkers

DECEMBER 12, 2019

In fact, they have the exact same problems as we do in ensuring that the active pharmaceutical ingredients (APIs) used to make our drugs are of the highest quality and without contaminants. Why do I write “exact same”? Because sometimes we’re dealing with same factories making the same APIs, which turn out to have problems.

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Drugs Manufacturing Medicine Regulation 71

Cloudbyz

AUGUST 19, 2024

They require the most stringent regulatory controls, including premarket approval (PMA), which involves rigorous testing and clinical trials to demonstrate safety and effectiveness before they can be marketed. What is the process for conducting clinical trials for medical devices?

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Delveinsight

SEPTEMBER 8, 2021

Pharma Consultants come up with various business strategies, technical or non-technical, management of quality control & testing, identifying relevant supplies and equipment, drug – design & development, and regulation of clinical trials. Pharma Consultancy Modus Operandi.

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