AAPS Advances in the Pharmaceutical Sciences Series

Sophia M. Shi

Li Di

Strategies to Optimize Peptide Stability and Prolong Half-Life

优化肽稳定性及延长半衰期的策略

Nan Zheng

Wenlei Jiang

Robert Lionberger

Lawrence X. Yu

FDA Bioequivalence Standards

Bioequivalence for Liposomal Drug Products

脂质体药物产品的生物等效性

Applied Pharmacometrics

应用药效学

Paul Harber

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products

环境敏感型药品分销的质量源于设计

Sarah J. Trenfield

Christine M. Madla

Abdul W. Basit

Simon Gaisford

3D Printing of Pharmaceuticals

The Shape of Things to Come: Emerging Applications of 3D Printing in Healthcare

未来的形态：3D打印在医疗领域的应用前景

Feroz Jameel

Principles and Practices of Lyophilization in Product Development and Manufacturing

Design of Moisture Specification Studies for Lyophilized Product

冻干产品水分规格研究设计

Dave A. Miller

Daniel Ellenberger

Tiago Porfirio

Marco Gil

Formulating Poorly Water Soluble Drugs

Spray-Drying Technology

喷雾干燥技术

The golden era of antibiotic discovery almost 60 years ago seems to be an interlude in the eternal battle against bacteria; the spread of resistant bacteria has led to the emergence of highly resistant pathogens and hard-to-treat infections. In vitro infection models have made it possible to gather time-course data regarding antibiotic and bacteria interaction. The main drawback of these in vitro systems is that they do not take into account the host immune system, drug-protein binding, and characteristics of the infection site. Hence, animal studies are important to gain insights into the host response and the progression of infection. Modeling antimicrobials has the distinct advantage wherein the target is readily accessible since the bacterial load can be quantified in both in vitro and in vivo experimental conditions. The increasing knowledge base about molecular mechanisms of interactions between antibiotics and antibiotic targets, coupled with advanced experimental techniques and computational capability, makes the development of mechanism-based PK/PD models incorporating receptor binding and bacterial physiology possible. This new generation of mechanism-based PK/PD models will enable the exploration and increased understanding of the underlying complex mechanisms of the infectious process. The transition toward systems-based approaches requires the ability to integrate diverse data types and experimental platforms. Most approaches for translating preclinical antimicrobial research focus only on antibiotic activity and interactions between the drug and bacteria. Mathematical modeling can assist in this process by integrating the behavior of multiple components into a comprehensive network-based model, and by addressing questions that are not yet accessible to experimental analysis.

出版信息	出版商: Springer Verlag，出版周期: ，期刊类型: book-series，开源期刊: 否
基本数据	创刊年份: 2014，原创研究文献占比: ，自引率:， Gold OA占比:

AAPS Advances in the Pharmaceutical Sciences Series

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Strategies to Optimize Peptide Stability and Prolong Half-Life

Bioequivalence for Liposomal Drug Products

Applied Pharmacometrics

Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products

The Shape of Things to Come: Emerging Applications of 3D Printing in Healthcare

Design of Moisture Specification Studies for Lyophilized Product

Strategies to Optimize Peptide Stability and Prolong Half-Life

Spray-Drying Technology

The Shape of Things to Come: Emerging Applications of 3D Printing in Healthcare

Translational Modeling of Antibacterial Agents