The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series
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Published By Springer International Publishing

9783030117504, 9783030117511

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Regulatory Landscapes for Approval of Naturally-Derived Complex Mixture Drugs

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_2 ◽

2019 ◽

pp. 17-44

Author(s):

Larisa C. Wu ◽

Andre Raw ◽

Werner Knöss ◽

Michael Smith ◽

Wei-Dong Zhang ◽

...

Keyword(s):

Complex Mixture ◽

Regulatory Landscapes

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Analytics on Farm Dust Extract for Development of Novel Strategies to Prevent Asthma and Allergic Disease

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_5 ◽

2019 ◽

pp. 79-90

Author(s):

Nathan Stebbins ◽

Erika von Mutius ◽

Ram Sasisekharan

Keyword(s):

Allergic Disease ◽

On Farm ◽

Dust Extract

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NMR in the Characterization of Complex Mixture Drugs

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_7 ◽

2019 ◽

pp. 115-137

Author(s):

Marco Guerrini ◽

Timothy R. Rudd ◽

Edwin A. Yates

Keyword(s):

Complex Mixture

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Scientific Considerations in the Approval of Complex Generics

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_9 ◽

2019 ◽

pp. 157-173

Author(s):

Andre S. Raw ◽

Larisa Wu

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Analytical Tools for Physicochemical Characterization and Fingerprinting

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_6 ◽

2019 ◽

pp. 91-113 ◽

Cited By ~ 1

Author(s):

David A. Keire

Keyword(s):

Physicochemical Characterization ◽

Analytical Tools

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A Totality-of-Evidence Approach to Ensuring Therapeutic Consistency of Naturally Derived Complex Mixtures

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_15 ◽

2019 ◽

pp. 265-270 ◽

Cited By ~ 1

Author(s):

Sau L. Lee

Keyword(s):

Complex Mixtures ◽

Totality Of Evidence

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Economic Considerations for Complex Mixture Drugs

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_16 ◽

2019 ◽

pp. 271-295

Author(s):

Sen Lin

Keyword(s):

Complex Mixture ◽

Economic Considerations

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Complex Natural Product Heparin: Biosynthesis, Biology, and Application via Synthetic Heparins

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_3 ◽

2019 ◽

pp. 45-58

Author(s):

Po-Hung Hsieh ◽

Jian Liu

Keyword(s):

Natural Product

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Immunogenicity Risks for Naturally Derived Complex Drugs

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_13 ◽

2019 ◽

pp. 219-244

Author(s):

Roshni Rao ◽

Daniela Verthelyi

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Raw Materials Production and Manufacturing Process Control Strategies

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-3-030-11751-1_10 ◽

2019 ◽

pp. 175-190

Author(s):

Suman Chandra ◽

Donald Stanford ◽

Edward Fletcher ◽

Larry A. Walker

Keyword(s):

Process Control ◽

Manufacturing Process ◽

Raw Materials ◽

Control Strategies ◽

Manufacturing Process Control

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The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences SeriesLatest Publications

TOTAL DOCUMENTS

H-INDEX

Published By Springer International Publishing

Regulatory Landscapes for Approval of Naturally-Derived Complex Mixture Drugs

Analytics on Farm Dust Extract for Development of Novel Strategies to Prevent Asthma and Allergic Disease

NMR in the Characterization of Complex Mixture Drugs

Scientific Considerations in the Approval of Complex Generics

Analytical Tools for Physicochemical Characterization and Fingerprinting

A Totality-of-Evidence Approach to Ensuring Therapeutic Consistency of Naturally Derived Complex Mixtures

Economic Considerations for Complex Mixture Drugs

Complex Natural Product Heparin: Biosynthesis, Biology, and Application via Synthetic Heparins

Immunogenicity Risks for Naturally Derived Complex Drugs

Raw Materials Production and Manufacturing Process Control Strategies

The Science and Regulations of Naturally Derived Complex Drugs - AAPS Advances in the Pharmaceutical Sciences Series
Latest Publications