‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances
The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materi...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Dispas, Amandine [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2018transfer abstract |
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| Schlagwörter: |
Method Operable Design Region (MODR) Separative analytical techniques |
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| Umfang: |
10 |
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| Übergeordnetes Werk: |
Enthalten in: The effect of increasing Body Mass Index on sperm quality of subfertile men - Kozopas, N. ELSEVIER, 2019, TrAC, Amsterdam |
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| Übergeordnetes Werk: |
volume:101 ; year:2018 ; pages:24-33 ; extent:10 |
| Links: |
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| DOI / URN: |
10.1016/j.trac.2017.10.028 |
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| 520 | |a The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. | ||
| 520 | |a The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. | ||
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10.1016/j.trac.2017.10.028 doi GBV00000000000179A.pica (DE-627)ELV042498090 (ELSEVIER)S0165-9936(17)30351-5 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Dispas, Amandine verfasserin aut ‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances 2018transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. Quality by Design (QbD) Elsevier Method Operable Design Region (MODR) Elsevier Separative analytical techniques Elsevier Pharmaceutical impurities Elsevier Analytical Quality by Design (AQbD) Elsevier Risk management Elsevier Design Space (DS) Elsevier Avohou, Hermane T. oth Lebrun, Pierre oth Hubert, Philippe oth Hubert, Cédric oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:24-33 extent:10 https://doi.org/10.1016/j.trac.2017.10.028 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 24-33 10 045F 540 |
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10.1016/j.trac.2017.10.028 doi GBV00000000000179A.pica (DE-627)ELV042498090 (ELSEVIER)S0165-9936(17)30351-5 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Dispas, Amandine verfasserin aut ‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances 2018transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. Quality by Design (QbD) Elsevier Method Operable Design Region (MODR) Elsevier Separative analytical techniques Elsevier Pharmaceutical impurities Elsevier Analytical Quality by Design (AQbD) Elsevier Risk management Elsevier Design Space (DS) Elsevier Avohou, Hermane T. oth Lebrun, Pierre oth Hubert, Philippe oth Hubert, Cédric oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:24-33 extent:10 https://doi.org/10.1016/j.trac.2017.10.028 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 24-33 10 045F 540 |
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10.1016/j.trac.2017.10.028 doi GBV00000000000179A.pica (DE-627)ELV042498090 (ELSEVIER)S0165-9936(17)30351-5 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Dispas, Amandine verfasserin aut ‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances 2018transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. Quality by Design (QbD) Elsevier Method Operable Design Region (MODR) Elsevier Separative analytical techniques Elsevier Pharmaceutical impurities Elsevier Analytical Quality by Design (AQbD) Elsevier Risk management Elsevier Design Space (DS) Elsevier Avohou, Hermane T. oth Lebrun, Pierre oth Hubert, Philippe oth Hubert, Cédric oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:24-33 extent:10 https://doi.org/10.1016/j.trac.2017.10.028 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 24-33 10 045F 540 |
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10.1016/j.trac.2017.10.028 doi GBV00000000000179A.pica (DE-627)ELV042498090 (ELSEVIER)S0165-9936(17)30351-5 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Dispas, Amandine verfasserin aut ‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances 2018transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. Quality by Design (QbD) Elsevier Method Operable Design Region (MODR) Elsevier Separative analytical techniques Elsevier Pharmaceutical impurities Elsevier Analytical Quality by Design (AQbD) Elsevier Risk management Elsevier Design Space (DS) Elsevier Avohou, Hermane T. oth Lebrun, Pierre oth Hubert, Philippe oth Hubert, Cédric oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:24-33 extent:10 https://doi.org/10.1016/j.trac.2017.10.028 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 24-33 10 045F 540 |
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10.1016/j.trac.2017.10.028 doi GBV00000000000179A.pica (DE-627)ELV042498090 (ELSEVIER)S0165-9936(17)30351-5 DE-627 ger DE-627 rakwb eng 540 540 DE-600 540 610 VZ 35.00 bkl 44.46 bkl Dispas, Amandine verfasserin aut ‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances 2018transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. Quality by Design (QbD) Elsevier Method Operable Design Region (MODR) Elsevier Separative analytical techniques Elsevier Pharmaceutical impurities Elsevier Analytical Quality by Design (AQbD) Elsevier Risk management Elsevier Design Space (DS) Elsevier Avohou, Hermane T. oth Lebrun, Pierre oth Hubert, Philippe oth Hubert, Cédric oth Enthalten in Elsevier Kozopas, N. ELSEVIER The effect of increasing Body Mass Index on sperm quality of subfertile men 2019 TrAC Amsterdam (DE-627)ELV002244268 volume:101 year:2018 pages:24-33 extent:10 https://doi.org/10.1016/j.trac.2017.10.028 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 35.00 Chemie: Allgemeines VZ 44.46 Klinische Pathologie VZ AR 101 2018 24-33 10 045F 540 |
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‘quality by design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances |
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‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances |
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The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. |
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The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. |
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The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods. |
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