Open Access Medical Books


Edited by Izet M. Kapetanovic .
540 pages .

Drug discovery and development process aims to make available medications that are 
safe and effective in improving the length and quality of life and relieving pain and 
suffering. However, the process is very complex, time consuming, and resource 
intensive, requiring multi-disciplinary expertise and innovative approaches. Recent 
estimates suggest that it takes up to 13.5 years and 1.8 billion U.S. dollars to bring a 
new drug to the market. There is a growing urgency to identify and develop more 
effective, efficient, and expedient ways to bring safe and effective products to the 
market. The drug discovery and developmental process relies on utilizing relevant 
and robust tools, methods, and models that are predictive of clinical effects in terms of 
diagnosis, prevention, therapy, and prognosis. There is a growing emphasis on 
translational research, a bidirectional bench to the bedside approach. The all-important 
predictivity depends on having robust, relevant, validated and qualified biomarkers 
for physiological and pathological effects of interest.
The first section, Introduction, presents an overview of the principles, approaches, 
processes, and status of drug discovery today with an eye towards the future.
The second section, Current Status and Future Directions, presents a broad picture of 
the current, emerging, and evolving state of the drug discovery and development. It 
discusses topics such as chemical genetics, combination of ancient traditional, 
conventional and evolving systems, biology approaches, role of evolutionary biology, 
personalized medicine, and interaction. Other topics, such as collaboration between 
academia, government, and a private sector, and a practical overview of drug 
development from a big pharma perspective are also explored.
Section 3, Models, deals with the existing and emerging models for evaluating efficacy 
and safety. While model systems provide useful information and approximation to 
human pathophysiology and pharmacology, it is important to keep in mind that these 
are only models. They may only be applicable to addressing specific questions, and 
care must be exercised in their extrapolations.
As discussed in Section 4, Tools, Methods and Biomarkers, having and utilizing the 
right tools is critical during the drug discovery and development process. Biomarkers 
represent physiological, biochemical, or pathophysiological parameters or sentinels 
which are intended to detect or monitor diseases, or the health status of an organism.
The aim is to decrease probability of failure, decrease drug development time, and 
improve resource utilization. Also, biomarkers can provide information that is not 
readily available otherwise, such as that due to a lack of acceptably invasive 
procedures or unrealistic time frames. Biomarkers can be used as indices of efficacy, 
toxicity and for selection of appropriate patient populations. However, there are many 
caveats and few validated biomarkers. Some of the issues include inter-laboratory 
variation, lack of adequate sensitivity, specificity and predictability, or adequate 
knowledge if the biomarkers are within a causative or only a correlative pathway.
The final section 5, Drug Delivery, discusses development of appropriate formulations 
for drug delivery to achieve reasonable bioavailability, access to a target site, desirable 
pharmacokinetic profile, and a practical dosing regimen. Many drug candidates due to 
their physicochemical properties suffer from a poor solubility and/or poor 
permeability. Consequently, the Biopharmaceutics Classification System (BCS) was 
developed to predict intestinal drug absorption, identify strategies, and improve the 
efficiency of drug development. Perhaps the most rapidly growing area in drug 
delivery involves nanotechnology and use of nanoparticles. Nanoparticles range in 
size between 1 and 100 nm. and have shown usefulness in enhancing bioavailability, 
providing sustained drug release, and enabling targeted delivery to specific sites in the 
body. These effects can help improve efficacy and decrease toxicity of drugs.
Furthermore, specific forms of nanoparticles, in addition to serving as drug delivery 
vehicles, can also serve as imaging agents, biosensors, and diagnostic agents. Another 
new approach involves the use of mesenchymal stem cells for targeted delivery of 
drugs and nanoparticles to tumors and sites of inflammation.
It is our hope that the readers find the book informative and that it stimulates new and 
innovative ideas to apply to drug discovery and development of the future.

Izet M. Kapetanovic
Division of Cancer Prevention, National Cancer Institute, Bethesda,


Part 1 Current Status and Future Directions 7

Chapter 1 Drug Discovery and Ayurveda: 
Win-Win Relationship Between
Contemporary and Ancient Sciences 9
Bhushan Patwardhan and Kapil Khambholja

Chapter 2 Evolutionary Biology and Drug Development 25
Pierre M. Durand and Theresa L. Coetzer

Chapter 3 Novel Oncology Drug Development 
Strategies in the Era of Personalised Medicine 43
C.R. Lemech, R.S. Kristeleit and H.T. Arkenau

Chapter 4 Drug Discovery into the 21st Century 69
Klaus Pors

Part 2 Models 97

Chapter 5 Genetically Engineered Mouse Models 
in Preclinical Anti-Cancer Drug Development 99
Sergio Y. Alcoser and Melinda G. Hollingshead

Chapter 6 Genetic Pharmacotherapy 125
Celia Gellman, Susana Mingote, Yvonne Wang, Inna Gaisler-Salomon and Stephen Rayport

Chapter 7 Critical Human Hepatocyte-Based In Vitro 
Assays for the Evaluation of Adverse Drug Effects 151
Albert P. Li

Chapter 8 The Use of In Vitro 3D Cell Models 
in Drug Development for Respiratory Diseases 169
Song Huang, Ludovic Wiszniewski and Samuel Constant

Part 3 Tools, Methods, and Biomarkers 191

Chapter 9 Chemical Biology: 
What is Its Role in Drug Discovery? 193
Lisa Pirrie and Nicholas J. Westwood

Chapter 10 Towards Understanding Drugs on 
the Molecular Level to Design Drugs of Desired Profiles 231
Jolanta Natalia Latosińska and Magdalena Latosińska

Chapter 11 De-Risking Drug Discovery 
Programmes Early with ADMET 275
Katya Tsaioun and Steven A. Kates

Chapter 12 Novel Approach to High Throughput Screening for Activators of Transcription Factors 295
Natalya Smirnova, Dmitry Hushpulian, Rajiv Ratan and Irina Gazaryan

Chapter 13 Assessment of Cell Cycle Inhibitors 
by Flow Cytometry 323
Paolo Cappella and Jürgen Moll

Chapter 14 Image-Based High-Content 
Screening in Drug Discovery 339
Marjo Götte and Daniela Gabriel

Chapter 15 Recent Advances in Biotherapeutics 
Drug Discovery and Development 363
Xiaotian Zhong, Peter Neumann, Michael Corbo and Evan Loh

Chapter 16 Drug Discovery by Aptamers 
in Protozoan Infectious Diseases 379
Carsten Wrenger and Henning Ulrich

Chapter 17 Streamlining ICH Q6B 
Analytical Testing of Biotherapeutics 391
Elizabeth Higgins, Elisabeth Kast and Amy Lachapelle

Chapter 18 Biomarkers in Drug Development: 
A Useful Tool but Discrepant
Results May Have a Major Impact 401
Abdel-Baset Halim

Part 4 Drug Delivery 425

Chapter 19 Nanotechnology Based Targeted Drug Delivery: Current 
Status and Future Prospects for Drug Development 427
Sadhna Sharma and Amandeep Singh

Chapter 20 Silver Nanoparticles – Universal Multifunctional 
Nanoparticles for Bio Sensing, Imaging for Diagnostics and Targeted Drug Delivery for Therapeutic Applications 463
Anitha Sironmani and Kiruba Daniel

Chapter 21 Mesenchymal Stem Cells 
as Vehicles for Targeted Therapies 489
Gabriele Putz Todd, Michelle A LeRoux and Alla Danilkovitch-Miagkova .

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Published by: Unknown - Monday, January 28, 2013


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