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.

Contamination 145

Contamination Clinical Trials Clinical Trials Protein 145

Worldwide Clinical Trials

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. Despite the higher yield, both sample types showed minimal protein contamination, indicating high purity levels.

Medicine 182

Medicine DNA Compliance Clinical Trials 182

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.

Contamination 45

Contamination Clinical Trials Clinical Trials Trials 45

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.

Trials 100

Trials Clinical Trials Clinical Trials Contamination 100

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

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.

Development 232

Development Production Regulation Clinical Trials 232

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. Only about 5% of eligible patients enroll in clinical trials, with minority populations representing an even lower percentage. [x]

Clinical Trials 69

Clinical Trials Clinical Trials Trials Drugs 69

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

Clinical Trials 40

Clinical Trials Clinical Trials Contamination Trials 40

Pharmaceutical Technology

MAY 10, 2023

Microparticles can be present as a contamination of products such as pharmaceuticals and electronics, or as an air pollutant. The LUMOS II II has proven an ideal tool for testing various substances for contamination in pharmaceutical contexts. Particle analysis on a micro-scale is a significant topic in several fields of application.

Contamination 130

Contamination Filler Bioavailability Production 130

XTalks

JULY 18, 2023

The drugmaker is facing more than 38,000 talc-related lawsuits, mostly over its iconic baby powder which plaintiffs claim was contaminated with asbestos that caused ovarian cancer and mesothelioma. In the formal complaint, LTL said they have made “careers and small fortunes” testifying for plaintiffs in talc trials.

Research 95

Research Contamination Doctors Doctor 95

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Biohazard 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Nurses 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Nurses 52

pharmaphorum

AUGUST 17, 2022

The first lawsuit claiming that gastrointestinal drug Zantac causes cancer has been voluntarily dismissed a week before it was due to come to trial, in an early victory for the pharma companies that will defend themselves from the allegations. The post First Zantac cancer case dropped before trial, without settlement appeared first on.

Trials 52

Trials Sales Contamination Pharma Companies 52

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.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

pharmaphorum

AUGUST 11, 2022

There are a couple of thousand legal complaints related to Zantac filed in the US, with a class action suit due to go to trial in Illinois later this month, with another scheduled to start in California in October.

Sales 105

Sales Contamination Marketing Production 105

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.

Development 180

Development Protein Production Hormones 180

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.

FDA Approval 98

FDA Approval Dermatology Trials Clinical Trials 98

STAT News

NOVEMBER 3, 2022

The trial is being conducted in the U.S. Plans for a $400 million investment by Eli Lilly in a new manufacturing plant in Limerick, Ireland, have been put on hold following an objection by a local landowner over concerns of flooding of his lands by contaminated water , The Irish Examiner reports.

Vaccination 97

Vaccination Vaccine Drug Delivery Systems Sales 97

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.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Production 98

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.

Vaccination 130

Vaccination Vaccine Life Science Immune Response 130

Pharmaceutical Technology

MAY 11, 2008

The trial allowed end-to-end traceability of haemophilia medication, which promoted secure deliveries, stock optimisation and greater patient safety. The trial was promoted by Dr Barry White, director of the NCHCD, after he became concerned about the safety of medication for haemophiliacs.

Drugs 100

Drugs Packaging Packaging Production 100

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. – is a big no-no.

Clinical Trials 98

Clinical Trials Clinical Trials Doctors Doctor 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.

Contamination 52

Contamination Bacteria Packaging Packaging 52

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

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

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.

Contamination 45

Contamination Clinical Trials Clinical Trials Containment 45

XTalks

AUGUST 3, 2021

Concerns of asbestos contamination in Johnson & Johnson’s talc-based formulations have been around since the 1970s, with the company accused of ignoring and failing to report them to the US Food and Drug Administration (FDA). For years, Johnson & Johnson denied the claims.

Containment 98

Containment Production Contamination Marketing 98

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.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

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.

Contamination 52

Contamination Vaccination Vaccine Pharmacy 52

XTalks

OCTOBER 26, 2020

Manufacturing packaging often pollutes the air with greenhouse gases, heavy metals and particulates and produces wastewater that contains potentially toxic contaminants. Here are some brands that have made the switch or are trialing new forms of packaging. But we’re beginning to see a shift. Testing Out Reusable Packaging.

Packaging 98

Packaging Packaging Marketing Containment 98

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.

Biobanking 80

Biobanking Contamination Life Science Packaging 80

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.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

XTalks

MARCH 10, 2022

Mined talc is prone to asbestos contamination because the two minerals are often found together in nature. The unsealed asbestos experiment files were unearthed in two trials last year pertaining to the baby powder. Johnson & Johnson discontinued selling the baby powder in the US and Canada in May 2020 citing a drop in demand.

Containment 98

Containment Dermatology Contamination Sales 98

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.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

Olympian Clinical Research

JANUARY 27, 2021

You worry about contamination and catching/spreading germs. We’ll be enrolling for a clinical trial next month designed specifically for OCD patients, and we’re hopeful that this study will help provide a solution for patients who are struggling from this condition. . then they could indicate OCD. .

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Research Trials 52

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.

Vaccination 52

Vaccination Vaccine Manufacturing Contamination 52

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.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59