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Investigational New Drug - DOAJ

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Last Updated: 06 August 2022

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Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world

We present an analysis of findings and outcome classifications from FDA inspections during Investigational New Drug studies and comparison the findings from the CEE region to those from Western European countries and the United States based on the FDA's publicly available Clinical Investigator Inspection Report. Clinical trials, testing, Central and Eastern Europe, data quality, and missings are among the key words used in this study. On the basis of FDA inspection findings, the high productivity of CEE sites appears to be accompanied by regulatory compliance, as well as data quality requirements that are not inferior to those in Western regions.

Source link: https://doaj.org/article/c392e5974c9441759cf7f272c137cc94


Development and investigational new drug application of mesenchymal stem/stromal cells products in China

Several biotech firms have invested significant money from the production of a clinical grade MSC product to the investigation of new drug enabling studies. Also, the increasing demand for the publication of MSC rules in China necessitates several articles in respected academic journals. The National Medical Products Administration has published regulations on the clinical use of MSCs therapy. In recent years in China, the Chinese rules regarding MSCs as drug have been updated.

Source link: https://doi.org/10.1002/sctm.21-0083


Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial

ASPIRE was a Phase 3 safety and effectiveness trial of a 25 mg dapivirine capsule for the prevention of HIV-1 in women. The trial involved 2629 women at 15 medical research sites in Malawi, Uganda, South Africa, and Zimbabwe who were randomized in a 1:1 ratio to receive either a ring of dapivirine containing 25 mg or a matching placebo vaginal ring. Our study results support the adoption of a double check dispensing system and real time accountability audits as standard practice in clinical trials.

Source link: https://doi.org/10.1016/j.conctc.2021.100859


Regulatory Affairs 101: Introduction to Investigational New Drug Applications and Clinical Trial Applications

Testing novel drugs on fellow human beings is fraught with potential ethical issues, but a moral imperative is developing drugs to treat a variety of human diseases and disorders. Medical studies on human subjects must be appropriately defended and subject to close scrutiny, according to global regulatory bodies, who are responsible for ensuring that medical research on human subjects are properly justified and subjected to close monitoring.

Source link: https://doi.org/10.1111/cts.12635


Retrospective evaluation of single patient investigational new drug (IND) requests in pediatric oncology

Abstract Background: Single patient Research is One of the two major approaches by which experimental therapies are available to cancer patients. Methods We conducted a retrospective review of all single patient INDs ordered and administered at a single center between 1/1/2007 and 5/1/2019. Over the course of two years of the study, we present aggregate data from the U. S. Food and Drug Administration on single patient IND trials across the last two years. Pediatric oncology's result over the course of 2 years The FDA accepted all 171 submitted single patient IND requests for pediatric oncology. The median duration of care was 84 days, with three patients remaining on medication at the time of analysis. In our national and single-center study, single patient INDs in pediatric oncology were universally approved. Single patient INDs were primarily used for agents that did not have a clinical trial in our cohort, rather than genomics, primarily based on disease histology, rather than genomics.

Source link: https://doi.org/10.1002/cam4.3791


A two-year evaluation of the minutes of Investigational New Drug committee meetings

Introducing: The Investigative New Drug committee advises the Drug Controller General of India on topics relating to human trials of IND for clinical research. Methods: The minutes of the IND committee's public domain's public domain were reviewed. The minutes of N = 7 meetings were available in the public domain for the period January 2017-to-December 2018, with N = 45 agenda items included. One agenda item was blacklisted, and n = 44 agenda items were finally reviewed. N = 19/29 were of the Indian origins of the n = 29 INDs reviewed. Although the majority of INDs discussed in the meetings were of Indian origins, the drug discovery was not in place to address the top ten causes of years of life lost prematurely.

Source link: https://doi.org/10.4103/picr.PICR_83_19

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions