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TEXTBOOK : DRUG DEVELOPMENT – A CASE STUDY BASED INSIGHT INTO MODERN STRATEGIES

DRUG DEVELOPMENT

Edited by Chris Rundfeldt .

654 pages .
Open Access .


The term “drug development” depicts the process leading from a selected chemical structure as drug development candidate to the application for marketing authorization.
During the development process three different aspects need to be elaborated: the chemical and pharmaceutical quality, the safety and toxicity profile, and the efficacy in patients. The majority of work conducted during the formal development process aims at generating the data required to submit a marketing application dossier, which will be reviewed by local authorities around the world for approval. The most important authorities are the Food and Drug Administration (FDA) in the US, the European Medicines Agency (EMA) and the Ministry of Health, Labor and Welfare (MHLW) in Japan. These agencies represent the major markets for pharmaceuticals.
Data generated during a drug development process should be suitable to be included into a dossier for marketing application in each of these countries and also in other regions. This, however, has not always been possible. In the 1980s, what is today the European Union began harmonizing regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonization; and only in April 1990 a structure was established which aimed at generating standards which are acceptable in all respective regions. This institution was called “International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use” (ICH). It is composed from the three regulatory agencies representing US, EU and Japan, but it also included participants from the pharmaceutical industry of these regions. The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration.
Since its establishment, the ICH has generated several guidelines and standards strictly regulating the requirements for successful drug development. Respective guidelines are often very detailed and describe the required data set and often even the way how such data are to be interpreted. At the same time, the ICH aims at being up to data to represent the best standard of current research. This requires constant update of guidelines and in part generation of novel regulations. Numerous guidelines have been generated and revised as needed in all three sections of drug development, i.e. the pharmaceutical section describing quality aspects of the drug substance and the drug product (guidelines Q1-Q11), safety aspects (guidelines S1-S9) and efficacy aspects (E1-E16). Multidisciplinary guidelines are M1-M8. All guidelines are accessible online.....


Chris Rundfeldt, Ph.D., DVM
Expert for Drug Development and Translational Medicine
Germany
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CONTENTS :




Part 1 Novel Approaches to Cancer Treatment .


 1 Discovery and Optimization of Inhibitors of DNA Methyltransferase as Novel Drugs for Cancer Therapy 3 Jakyung Yoo and José L. Medina-Franco

 2 Development of Novel Secondary Hormonal Therapies for Castrate-Resistant Prostate Cancer 23 Rahul Aggarwal and Charles J. Ryan

 3 Inhibitors of Proteinases as Potential Anti-Cancer Agents 39 Karolina Gluza and Paweł Kafarski

 4 Histamine Receptors as Potential Therapeutic Targets for Cancer Drug Development 75 Vanina A. Medina, Diego J. Martinel Lamas, Pablo G. Brenzoni, Noelia Massari, Eliana Carabajal and Elena S. Rivera

 5 Histone Deacetylase Inhibitors as Therapeutic Agents for Cancer Therapy: Drug Metabolism and Pharmacokinetic Properties 101 Ethirajulu Kantharaj and Ramesh Jayaraman

Part 2 Anti-Infectives .


 6 Antimicrobial Peptides: New Frontiers in the Therapy of Infections 123 Mario Zucca, Sara Scutera and Dianella Savoia

 7 microRNAs as Therapeutic Targets to Combat Diverse Human Diseases 163 Elizabeth Hong-Geller and Nan Li

 8 Potentiation of Available Antibiotics by Targeting Resistance – An Emerging Trend in Tuberculosis Drug Development 183 Kerstin A. Wolff, Marissa Sherman and Liem Nguyen

 9 Antitubercular Drugs Development: Recent Advances in Selected Therapeutic Targets and Rational Drug Design 207 Virgilio Bocanegra-García, Abraham García, Jose Prisco Palma-Nicolás, Isidro Palos and Gildardo Rivera

 10 Insight into the Key Structural Features of Potent Enoyl Acyl Carrier Protein Reductase Inhibitors Based on Computer Aided Molecular Design 243 Auradee Punkvang, Pharit Kamsri,
Kodchakon Kun-asa,Patchreenart Saparpakorn, Supa Hannongbua, Peter Wolschann and Pornpan Pungpo

Part 3 Novel Targets and Technologies Leading to Improved Treatment Options .


 11 RNA Interference-Based Therapeutics: Harnessing the Powers of Nature 265 Tamara Martinez, Natalia Wright, Covadonga Paneda, Ana I. Jimenez and Marta Lopez-Fraga

 12 P2X Receptors as New Therapeutic Targets 313 Liang Xin, Xiao Yanjuan and Li Zhiyuan

 13 Pregnane X Receptor in Drug Development 337 Su Sien Ong, Yue-Ming Wang, Sergio C. Chai and Taosheng Chen

 14 Crosstalk Between the Immune and Central Nervous Systems with Special Reference to Drug Development 365 Takekazu Kubo, Shigeru Tokita and Toshihide Yamashita

15 Liquiritigenin Attenuates Alzheimer’s-Like Neuropathology in an Amyloid Protein Precursor Transgenic Mouse Model and the Underlying Mechanisms 381 Rui Ting Liu, Jin Tian Tang, Li Bo Zou, Jie Ying Fu and Qiu Jun Lu

 16 Novel Therapeutic Strategies for Chagas` Disease 399 Alane Beatriz Vermelho, Carlos Alberto Manssour Fraga, Samir Aquino Carvalho, Edson Ferreira da Silva, Solange Lisboa de Castro, Igor de Almeida Rodrigues, Maria do Socorro dos Santos Rosa, Ana Claudia Fernandes Amaral and Giseli Capaci Rodrigues

 17 The Gut Microbiota as Target for Innovative Drug Development: Perspectives and a Case Study of Inflammatory Bowel Diseases 437 Joan Vermeiren, Sam Possemiers, Massimo Marzorati and Tom Van de Wiele

 18 Endophytic Fungi of Tropical Forests: A Promising  Source of Bioactive Prototype Molecules for the Treatment of Neglected Diseases 469 Luiz H. Rosa, Mariana L.A. Vieira, Betania B. Cota, Susana Johann,Tânia M.A. Alves, Carlos L. Zani and Carlos A. Rosa

 19 Bioproduction of Depsidones for Pharmaceutical Purposes 487 María Estrella Legaz, Roberto de Armas and Carlos Vicente

 20 Multi-Dose Container for Nasal and Ophthalmic Drugs: A Preservative Free Future? 509 Degenhard Marx and Matthias Birkhoff

 21 Microneedle-Assisted Transdermal Delivery of Opioid Antagonists for the Treatment of Alcoholism 525 Stan L. Banks, Audra L. Stinchcomb and Kalpana S. Paudel

Part 4 Drug Development Strategies .


 22 Innovative Proposals for Incentivizing Drug Development 545 Kristina M. Lybecker

 23 Drug Experimentation in Healthy Volunteers 561 Giovanni Gori, Giuseppe Pasqualetti, Catia Castiglioni, Corrado Blandizzi and Mario Del Tacca

 24 Changes in Research and Development of Medicinal Products since the Paediatric Regulation 585 Adriana Ceci, Mariana Catapano, Cristina Manfredi, Ian Wong, Mine Orlu-Gul, Annarita Meneguz, Paola Baiardi, Oscar Della Pasqua, Achille Iolascon, Maurizio Scarpa and Antje Neubert




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