Pentosan Polysulfate Sodium

 

 

Bibliography - Link

 

Pentosan polysulfate (PPS, (1->4)-β-Xylan 2,3-bis(hydrogen sulfate) with a 4 O-methyl-α-D-glucuronate) is a semi-synthetic polysulfated xylan sold for the relief of various medical conditions including thrombi and interstitial cystitis in humans and osteoarthritis in dogs and horses.

 

 

Clinical Investigation


Impact of the REGULATION (EU) No 536/2014 on clinical trials 

NextraResearch S.r.l. is qualified stakeholder: “Overview of comments received on 'Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products' (EMEA/CHMP/SWP/28367/07 Rev. 1)” - 20 September 2017 EMA/CHMP/853503/2016 Committee for Medicinal Products for Human Use (CHMP)

 

Impact of the Revised EU Clinical Trial Regulation

Posted 24 April 2017 | By Siegfried Schmitt, PhD, Federico Bonacci, MD, Daniela Lisini, PhD, Viviana Mascilongo, PhD 

Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulation are still underway, readers will benefit from the assessment of its current status and anticipated developments.  

Full text available on   http://www.raps.org/Regulatory-Focus/Features/2017/04/24/27396/Impact-of-the-Revised-EU-Clinical-Trial-Regulation/  

 

Available by:  https://www.bookrepublic.it/book/9788862615570-practical-handbook-of-clinical-investigation/

The clinical trials legislation has undergone significant changes in the past years, both in the figures responsible for the authorization process and the procedures to obtain the necessary authorizations.This volume comes from the need to cover an editorial gap and make a reference book available that could be useful for anyone working on clinical trials: for the novice and for those who feel the need to review or investigate themes and concepts already known.The manual deals with the aspects of the clinical trial for the different types of products (medicinal products for human use, medical devices, veterinary drugs, cosmetics, nutraceuticals, ...) without forgetting the fundamental regulatory rules and the necessary theoretical knowledge (methodology and ethics, safety, statistical methods).

 

 

 

Scientific References on various Topics

 

1) air leak after pulmonary resection

Efficacy and safety of Innoseal for air leak after pulmonary resection: a case-control study

Francesco Petrella, MDCorrespondence information about the author MD Francesco PetrellaThis email address is being protected from spambots. You need JavaScript enabled to view it., Alessandro Borri, MD, Daniela Brambilla, PhD, Giorgio Calanca, PhD, Nicola Vezzani, PhD, Antonio Colantoni, PhD, Adolfo Gasparetto, MD, Lorenzo Spaggiari, MD

Dr. Adolfo Gasparetto – London 2016

LINK

 

2) eCTD

eCTD: A Global Regulatory Overview by Viviana Mascilongo - regulatoryfocus.org -  March 2018

Full text available on demand by: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

 

3) Veterinary Devices

    a) US and EU Veterinary Medical Device Regulation By Viviana Mascilongo and Sharnée Nichols - regulatoryfocus.org April 2018

       

      LINK

 

    b) Veterinary Borderline Products, Veterinary Medical Devices and In Vitro Diagnostics: Global Regulatory Overview

         By Fabrizio Bertani, DVM, Melinda J. Mayfield, DVM, WCHP-AH, Viviana Mascilongo, PhD, Sharnée Nichols, RVT

       

      LINK

 

 

 

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