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Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part II-A Method of Software Documentary Analysis

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2012
1688.pdf (3.749Mb)
Authors
Ilić, Nina
Savić, Snežana
Siegel, Evan
Atkinson, Kerry
Tasić, Ljiljana
Article (Published version)
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Abstract
A wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the... previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:909-920

Keywords:
Cellular therapy / Clinical translation / Clinical trials / Ethics
Source:
Stress-The International Journal on the Biology of Stress, 2012, 1, 12, 909-920
Publisher:
  • Wiley, Hoboken

DOI: 10.5966/sctm.2012-0038

ISSN: 2157-6564

PubMed: 23283552

WoS: 000312823200006

Scopus: 2-s2.0-84872946357
[ Google Scholar ]
15
11
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1690
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Ilić, Nina
AU  - Savić, Snežana
AU  - Siegel, Evan
AU  - Atkinson, Kerry
AU  - Tasić, Ljiljana
PY  - 2012
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1690
AB  - A wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:909-920
PB  - Wiley, Hoboken
T2  - Stress-The International Journal on the Biology of Stress
T1  - Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part II-A Method of Software Documentary Analysis
VL  - 1
IS  - 12
SP  - 909
EP  - 920
DO  - 10.5966/sctm.2012-0038
ER  - 
@article{
author = "Ilić, Nina and Savić, Snežana and Siegel, Evan and Atkinson, Kerry and Tasić, Ljiljana",
year = "2012",
abstract = "A wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:909-920",
publisher = "Wiley, Hoboken",
journal = "Stress-The International Journal on the Biology of Stress",
title = "Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part II-A Method of Software Documentary Analysis",
volume = "1",
number = "12",
pages = "909-920",
doi = "10.5966/sctm.2012-0038"
}
Ilić, N., Savić, S., Siegel, E., Atkinson, K.,& Tasić, L.. (2012). Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part II-A Method of Software Documentary Analysis. in Stress-The International Journal on the Biology of Stress
Wiley, Hoboken., 1(12), 909-920.
https://doi.org/10.5966/sctm.2012-0038
Ilić N, Savić S, Siegel E, Atkinson K, Tasić L. Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part II-A Method of Software Documentary Analysis. in Stress-The International Journal on the Biology of Stress. 2012;1(12):909-920.
doi:10.5966/sctm.2012-0038 .
Ilić, Nina, Savić, Snežana, Siegel, Evan, Atkinson, Kerry, Tasić, Ljiljana, "Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part II-A Method of Software Documentary Analysis" in Stress-The International Journal on the Biology of Stress, 1, no. 12 (2012):909-920,
https://doi.org/10.5966/sctm.2012-0038 . .

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