Cloudbyz

JULY 2, 2024

Understanding the exceptions in Informed consent is an essential aspect of ethical clinical research because it concerns full awareness of risks and benefits related to research, as well as procedures. This is particularly relevant for infectious diseases where rapid diagnosis and treatment are important in disease control before its spread.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 5, 2024

Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi has emphasised that the medical devices and in-vitro diagnostics (IVD) sold in the county should be tested for the standards prescribed by the Bureau of Indian Standards (BIS) for its quality and performance in the country.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

All the medical devices including in-vitro diagnostic medical devices have come under the regulation […]

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In-Vitro Licensing Licensing Regulation 189

Pharma Mirror

MARCH 8, 2021

1] It became continually challenging in targeting KRAS transformation bearing tumors in view of the unclear construction of the protein, however by a wide margin but AMG 510, an effective inhibitor was brought into these clinical preliminaries. [2] 2] Presumably, fenbendazole multitherapy along with this little.

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In-Vitro Drugs Protein Research 246

Pharma Mirror

SEPTEMBER 2, 2021

In-vitro studies conducted at the British virology research laboratory Virology Research Services in London then demonstrated a potent antiviral activity against SARS-CoV-2 and other RNA viruses. Code Pharma discovered that the peptide had a direct antiviral effect against SARS-CoV-2, the novel Coronavirus causing COVID-19.

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In-Vitro RNA Clinical Trials Clinical Trials 245

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2025

The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

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Licensing Licensing In-Vitro Regulation 180

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 1, 2023

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

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RNA DNA In-Vitro Drugs 189

Worldwide Clinical Trials

DECEMBER 19, 2024

In-Vitro Diagnostic Regulation and The FDAs Final Rule The WODC U.S. discussion also briefly mentioned the FDAs Final Rule, which seems to run parallel with the EUs In-Vitro Diagnostic Regulation (IVDR). One topic that sparked this dialogue is the potential bankruptcy of 23andMe, a direct-to-consumer genetic testing company.

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Genetics In-Vitro Drugs Clinical Trials 130

Scienmag

NOVEMBER 17, 2020

Researchers at Karolinska Institutet in Sweden report promising results from an in vitro combination therapy against COVID-19. Credit: Martin Stenmark.

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In-Vitro Medicine Trials Research 59

BioSpace

JULY 19, 2021

Preclinical data for its drug candidate, LP-184, reportedly showed over 90 percent efficacy in shrinking pancreatic cancer tumors in mouse models in vitro, in-vivo, and ex-vivo.

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In-Vivo In-Vitro Drugs 145

Medical Xpress

MARCH 1, 2023

In the worst-case scenario, getting chemicals in your eyes can lead to blindness. Until now, the eye irritancy potential of chemical substances has had to be assessed using the Draize test on live rabbits—a standard implemented worldwide.

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Pharmaceutical Technology

MAY 4, 2023

The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results. This cohort showed a safety profile identical to that found in older children and adults.

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In-Vitro Genetic Disease Medicine Genetics 246

Pharmaceutical Technology

OCTOBER 5, 2022

Autologous CAR-T therapy does not easily lend itself to treating CLL, as it relies on extracting functional T-cells from the patient’s blood and genetically modifying them in vitro. Autologous CAR-T agents are now becoming the standard of care for patients in the third line and later settings, providing lucrative returns for these agents.

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In-Vitro In-Vivo Sales Clinical Trials 279

BioSpace

JANUARY 25, 2021

An in vitro study conducted by scientists from Northwestern University and Utah State University concluded that components found within the Xlear nasal spray, particularly grapefruit seed extract and xylitol, were successful in statistically reducing the amount of SARS-CoV-2 in a patient.

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In-Vitro Scientist 145

Medical Xpress

MAY 16, 2023

That was the case when Thilini Gamage was to carry out one of the studies in her doctoral work with Professor Eirik Frengen at the Institute of Clinical Medicine, University of Oslo. They study gene variation and mutations that cause rare genetic diseases. A mutation is a permanent change in the genetic material.

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In-Vitro In-Vivo Genetic Disease Genetics 98

pharmaphorum

APRIL 9, 2024

Navigating the complex path towards commercialising In Vitro Diagnostics (IVDs) can be challenging. Learn more about the intricate process involved in bringing early diagnostic tools to market.

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In-Vitro Marketing 116

Pharmaceutical Technology

JANUARY 4, 2023

A synergistic activity was also observed between the anti-Gremlin1 antibody and enzalutamide against castration-resistant prostate cancer models derived from patients in vitro and in vivo. TST003 is a first-in-class Gremlin1 targeting humanised monoclonal antibody.

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Antibody In-Vivo In-Vitro Protein 242

Bio Pharma Dive

FEBRUARY 28, 2024

The company is still attempting to “monetize” its most advanced drug, a treatment to aid pregnancy via in vitro fertilization.

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In-Vitro Drugs 124

Pharma Times

JANUARY 27, 2021

System will allow ‘in vitro diagnostics devices a faster and easier route to market’

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In-Vitro Marketing 117

BioPharma Reporter

JANUARY 28, 2021

In vitro studies found the Pfizer/BioNTech COVID-19 vaccine elicits antibodies against both the UK and South African virus strains.

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In-Vitro Vaccine Vaccination Antibody 119

XTalks

NOVEMBER 25, 2024

XTALKS WEBINAR: Enhance Early Biomarker Discovery: Translating In Vitro and In Vivo Multi-Omics Oncology Data Live and On-Demand: Thursday, January 16, 2025, at 11am EST (4pm GMT/UK) Register for this free webinar to learn how to harness the full potential of multi-omics data and advanced patient models to drive early biomarker discovery.

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In-Vivo FDA Approval In-Vitro Drugs 105

Scienmag

OCTOBER 20, 2020

The cover for issue 31 of Oncotarget features Figure 4, ‘Concentration dose-response curves of sirolimus effect [55 nM-1 nM] on the number of cells per surviving colony in U2OS cell line after 2 weeks exposure,’ by Vasuri, et al. Credit: Correspondence to – Gianandrea Pasquinelli – gianandr.pasquinelli@unibo.it

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In-Vitro Medicine 79

World of DTC Marketing

JULY 12, 2021

And both companies have performed in vitro tests that demonstrate satisfactory vaccine efficacy against variants of concern. SUMMARY: Pfizer says it has data on waning immunity from their COVID vaccine. The FDA and CDC say “not so fast.” ” Booster shots could bring billions in revenue to Pfizer and Moderna.

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Vaccine Vaccination In-Vitro Doctors 292

Pharmaceutical Technology

APRIL 14, 2023

All the new GD2 CAR designs developed through the partnership will be validated via in vitro screens and in vivo murine models. All the new GD2 CAR designs developed through the partnership will be validated via in vitro screens and in vivo murine models. Topic sponsors are not involved in the creation of editorial content.

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In-Vivo Gene Therapy In-Vitro Engineer 264

Medical Xpress

APRIL 11, 2023

In the process of organoid manufacturing, bioprinting technology can not only facilitate the creation and maintenance of complex biological 3D shapes and structures, but also allow for standardization and quality control during production.

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In-Vitro Manufacturing Production 71

Pharma Mirror

APRIL 21, 2024

In vitro transcribed (IVT) mRNA has been successfully The post General Design Methods for mRNA Drugs appeared first on Pharma Mirror Magazine. Scientists have been striving to optimize mRNA stability, immunogenicity, translation efficiency, and delivery systems to achieve efficient and safe mRNA delivery.

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In-Vitro Drugs Genetic Disease RNA 130

Pharmaceutical Technology

JULY 15, 2022

Despite entering its fourth decade of availability, in vitro fertilization (IVF), a medical technique used to facilitate the conception of a baby for those facing fertility problems, remains an elusive dream for many. Doing so will be vital in slowing the pace at which populations are ageing. Ageing populations increase the need to breed.

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In-Vitro Production Regulation Research 264

WCG Clinical

NOVEMBER 20, 2023

To view it please enter your password below: Password: The post A Review Of The Regulatory Landscape for In Vitro Gametogenesis appeared first on WCG. This content is password protected.

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In-Vitro 40

Pharma Mirror

AUGUST 30, 2022

The Test Bed utilizes Cytocentric principles, an innovative philosophy of putting the needs of the vulnerable cells front and center while growing and manipulating them in vitro. By eliminating the fluctuations and suboptimal transients caused by.

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Medicine In-Vitro Manufacturing Production 130

Outsourcing Pharma

JANUARY 18, 2022

The pharmaceutical company reports studies have demonstrated the main protease inhibitor of Paxlovid maintains in vitro efficiency against the variant.

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In-Vitro Research 97

Medical Xpress

MAY 15, 2023

A new research paper, titled "In vitro and in vivo effects of zoledronic acid on senescence and senescence-associated secretory phenotype markers," was published on the cover of Aging

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In-Vivo In-Vitro Research 98

Scienmag

OCTOBER 24, 2021

Many diagnosed patients relapse, despite radical resection of the primary oral squamous cell carcinoma (OSCC) lesion. Therefore, understanding the local invasion mechanism is warranted in developing more effective therapeutic approaches, and identifying markers that predict poor prognosis. Credit: Niigata University Niigata, Japan – […].

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Pharma Mirror

FEBRUARY 18, 2021

Maculus plans to raise USD3 million on a USD8 million valuation for a 12-18 month period, including initial in-vivo animal studies and completion of in-vitro / in-vivo drug elution studies. Maculus achieved the breakthrough using a patented novel tunable biodegradable proprietary product, MacuBloc. Capable of delivering any FDA approved.

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Drug Delivery In-Vivo In-Vitro Drugs 130

BioPharma Reporter

JANUARY 25, 2021

An in vitro study shows Moderna's existing mRNA COVID-19 vaccine provides protection against strains that have emerged from South Africa and the UK. But it does suggest reduced protection against the South Africa strain, and so the company is also developing a new booster designed for maximum efficacy against this variant.

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Vaccine Vaccination In-Vitro Development 105

XTalks

JANUARY 15, 2021

Ortho Clinical Diagnostics received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its VITROS SARS-CoV-2 antigen test for detection of active COVID-19 infection. The company says it can deliver five million tests a month and can increase to 15 million tests a month by February. active virus).

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Medical Xpress

JANUARY 25, 2023

Research from Dr. Michael Golding's laboratory at Texas A&M University indicates that male alcohol use has a significant negative influence on in vitro fertilization (IVF) success rates, thus increasing patient financial burden and emotional stress.

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In-Vitro Research 98

Medical Xpress

JANUARY 23, 2023

The new approach worked more quickly than existing techniques to eliminate clots formed in an in vitro model of cerebral venous sinus thrombosis (CVST). Researchers have developed a new tool and technique that uses "vortex ultrasound"—a sort of ultrasonic tornado—to break down blood clots in the brain.

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In-Vitro Development Research Cardiology 98