By Maria Cristina Galli, Mercedes Serabian

ISBN-10: 3319186175

ISBN-13: 9783319186177

ISBN-10: 3319186183

ISBN-13: 9783319186184

This ebook discusses different regulatory pathways for gene treatment (GT) and mobilephone remedy (CT) medicinal items carried out by way of nationwide and overseas our bodies during the global (e.g. North and South the United States, Europe, and Asia). each one bankruptcy, authored by means of specialists from a number of regulatory our bodies in the course of the overseas group, walks the reader throughout the purposes of nonclinical learn to translational medical examine to licensure for those cutting edge items. extra particularly, each one bankruptcy bargains insights into basic issues which are crucial for builders of CT and GT items, within the parts of product production, pharmacology and toxicology, and medical trial layout, in addition to pertinent "must-know" directions and laws.

Regulatory points of Gene treatment and cellphone treatment items: a world standpoint is a part of the American Society of Gene and mobilephone remedy sub-series of the hugely profitable Advances in Experimental medication and Biology series. it really is crucial analyzing for graduate scholars, clinicians, and researchers attracted to gene and telephone treatment and the rules of pharmaceuticals.

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This document describes the importance of (1) adequate equipment and manufacturing environment, (2) trained personnel, (3) adherence to procedures and practices that are well defined and documented for environmental monitoring, (4) raw material qualification and manufacturing, (5) establishment of a quality control unit that is independent from manufacturing to review procedures for production and lot release testing, and (6) investigation of deviations and initiation of corrective actions. 2 Pharmacology/Toxicology Prior to the administration of an investigational GCT product in a clinical trial, the sponsor must provide “[a]dequate information [in the IND] about the pharmacological and toxicological studies…on the basis of which [they have] concluded that it is reasonably safe to conduct the proposed clinical investigations.

Involving recombinant DNA. The NIH Guidelines also define the responsibilities of NIH, the RAC, investigators, and institutions. Under the NIH Guidelines, the RAC is responsible for providing recommendations to the NIH Director regarding the content and implementation of the NIH Guidelines. Prior to the creation of the NIH Guidelines, Congress and local governments were considering the development of regulations or local ordinances to restrict recombinant DNA research. During the early 1980s, in anticipation of the scientific, safety, and ethical issues that would arise when genetic engineering extended into humans, a presidential commission established to examine these issues published the report, Splicing Life [4].

Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products (2013). pdf 23. Guidance for Industry: Special Protocol Assessment (2002). pdf 24. Guidance for Industry: Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (2009). pdf 25. Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics (2014). pdf 26. Guidance for Industry: Expanded Access to Investigational Drugs for Treatment Use—Qs & As (2013).

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Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective by Maria Cristina Galli, Mercedes Serabian


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