國立高雄大學圖資館 |

語系: 繁體中文

說明(常見問題)

圖資館首頁

登入

回首頁

切換: 標籤 | MARC模式 | ISBD

The science and regulations of natur...

Sasisekharan, Ram.

The science and regulations of naturally derived complex drugs

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	The science and regulations of naturally derived complex drugsedited by Ram Sasisekharan ... [et al.].
其他作者:	Sasisekharan, Ram.
出版者:	Cham :Springer International Publishing :2019.
面頁冊數:	vi, 331 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
標題:	DrugsAnalysis.
電子資源:	https://doi.org/10.1007/978-3-030-11751-1
ISBN:	9783030117511$q(electronic bk.)

The science and regulations of naturally derived complex drugs
The science and regulations of naturally derived complex drugs[electronic resource] /edited by Ram Sasisekharan ... [et al.]. - Cham :Springer International Publishing :2019. - vi, 331 p. :ill., digital ;24 cm. - AAPS advances in the pharmaceutical sciences series,v.322210-7371 ;. - AAPS advances in the pharmaceutical sciences series ;3..

Evolving Challenges in Developing Naturally-Derived Complex Mixtures into Drugs: U.S. Experience and Perspective -- Regulatory Landscapes for Approval of Naturally-derived Complex Mixture Drugs -- Complex Natural Product Heparin: Biosynthesis, Biology and Application via Synthetic Heparins -- Traditional Chinese Medicine Herbal Drugs: From Heritage to Future Developments -- Analytics on Farm-Dust Extract for Development of Novel Strategies to Prevent Asthma and Allergic Disease -- Analytical Tools for Physicochemical Characterization and Fingerprinting -- NMR in the Characterization of Complex Mixture Drugs -- Mass Spectrometry in the Characterization of Complex Drugs -- Scientific Considerations in the Approval of Complex Generi -- Raw Materials Production and Manufacturing Process Control Strategies -- Heparin Contamination and Issues Related to Raw Materials and Controls -- Pharmacology and Toxicology Concerns of Impurities -- Immunogenicity risks for Naturally Derived Complex Drugs -- Development of Plant-Derived Mixtures as Botanical Drugs: Clinical Considerations -- A Totality-of-Evidence Approach to Ensuring Therapeutic Consistency of Naturally Derived Complex Mixtures -- Economic Considerations for Complex Mixture Drugs -- Drug Discovery from Complex Mixtures: Serendipity, Screening and Characterization -- Integrated Approach for Characterization of Highly Heterogeneous Drugs.

This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin) The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.

ISBN: 9783030117511$q(electronic bk.)

Standard No.: 10.1007/978-3-030-11751-1doiSubjects--Topical Terms:

204967
Drugs
--Analysis.

LC Class. No.: RS380 / .S354 2019

Dewey Class. No.: 615.19

The science and regulations of naturally derived complex drugs
LDR:04249nmm a2200337 a 4500 001 556631
003 DE-He213
005 20190906160122.0
006 m d
007 cr nn 008maaau
008 191127s2019 gw s 0 eng d
020 $a 9783030117511$q(electronic bk.)
020 $a 9783030117504$q(paper)
024 7 $a 10.1007/978-3-030-11751-1 $2 doi
035 $a 978-3-030-11751-1
040 $a GP $c GP
041 0 $a eng
050 4 $a RS380 $b .S354 2019
072 7 $a TDCW $2 bicssc
072 7 $a MED072000 $2 bisacsh
072 7 $a TDC $2 thema
082 0 4 $a 615.19 $2 23
090 $a RS380 $b .S416 2019
245 0 4 $a The science and regulations of naturally derived complex drugs $h [electronic resource] / $c edited by Ram Sasisekharan ... [et al.].
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2019.
300 $a vi, 331 p. : $b ill., digital ; $c 24 cm.
490 1 $a AAPS advances in the pharmaceutical sciences series, $x 2210-7371 ; $v v.32
505 0 $a Evolving Challenges in Developing Naturally-Derived Complex Mixtures into Drugs: U.S. Experience and Perspective -- Regulatory Landscapes for Approval of Naturally-derived Complex Mixture Drugs -- Complex Natural Product Heparin: Biosynthesis, Biology and Application via Synthetic Heparins -- Traditional Chinese Medicine Herbal Drugs: From Heritage to Future Developments -- Analytics on Farm-Dust Extract for Development of Novel Strategies to Prevent Asthma and Allergic Disease -- Analytical Tools for Physicochemical Characterization and Fingerprinting -- NMR in the Characterization of Complex Mixture Drugs -- Mass Spectrometry in the Characterization of Complex Drugs -- Scientific Considerations in the Approval of Complex Generi -- Raw Materials Production and Manufacturing Process Control Strategies -- Heparin Contamination and Issues Related to Raw Materials and Controls -- Pharmacology and Toxicology Concerns of Impurities -- Immunogenicity risks for Naturally Derived Complex Drugs -- Development of Plant-Derived Mixtures as Botanical Drugs: Clinical Considerations -- A Totality-of-Evidence Approach to Ensuring Therapeutic Consistency of Naturally Derived Complex Mixtures -- Economic Considerations for Complex Mixture Drugs -- Drug Discovery from Complex Mixtures: Serendipity, Screening and Characterization -- Integrated Approach for Characterization of Highly Heterogeneous Drugs.
520 $a This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin) The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.
650 0 $a Drugs $x Analysis. $3 204967
650 1 4 $a Pharmaceutical Sciences/Technology. $3 338426
650 2 4 $a Pharmacy. $3 218145
700 1 $a Sasisekharan, Ram. $3 838861
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer eBooks
830 0 $a AAPS advances in the pharmaceutical sciences series ; $v 3. $3 559046
856 4 0 $u https://doi.org/10.1007/978-3-030-11751-1
950 $a Biomedical and Life Sciences (Springer-11642)