Industrial chemistry and chemical engineering Books

Book SynopsisNonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Trade Review“As a toxicologist with a quarter-century of experience in pharmaceutical drug development, I found the reading of this book thoroughly enjoyable and useful.” (British Toxicology Society Newsletter, 1 October 2013) Table of ContentsList of Contributors xvii Preface xix Part I International Regulations and Nonclinical Studies for Pharmaceuticals 1 1 Introduction 3 Kathy M. McGown and William J. Brock 1.1 The Global Pharmaceutical Market 6 1.2 Looking to the Future 9 1.3 Legal and Regulatory Considerations in Drug Development 10 1.4 The Drug Development Process – General Considerations 12 2 ICH: History and Nonclinical Guidances 17 Jan-Willem van der Laan and Kenneth L. Hastings 2.1 Introduction 17 2.2 Organization of the ICH 19 2.3 The ICH Process 20 2.4 Animal Welfare and Alternative Methods 22 2.5 ICH M3 23 2.6 New Initiatives and Topics 24 3 Food and Drug Administration: Nonclinical Program and Pharmaceutical Approval 27 William J. Brock and Kenneth L. Hastings 3.1 Legislative Authority of the FDA 27 3.2 Nonclinical Drug Development and the FDA 31 3.3 Nonclinical Testing: General Conditions and Considerations 34 3.4 Toxicity Testing: Small Molecules and Traditional Pharmaceuticals 34 3.5 Toxicity Testing of Pharmaceuticals – The General Approach 35 3.6 First-in-Human Dosing: Results from Nonclinical Studies 37 4 Nonclinical Pharmaceutical Development in MERCOSUR and Brazil 41 Cristiana Leslie Corr^ea, Giuliana Selmi, and Flavio Ailton Duque Zambrone 4.1 Introduction 41 4.2 MERCOSUR 41 4.3 Brazil 44 5 Nonclinical Safety Assessment: Canada 57 Jamie L. Doran and Mark T. Goldberg 5.1 Introduction 57 5.2 Organization of Health Canada 58 5.3 The Regulatory Framework for Drug Approval in Canada 60 5.4 Nonclinical Assessment in Canada 64 5.5 Clinical Trial Applications 70 5.6 Special Regulatory Considerations 74 6 European Pharmaceutical Regulation – Nonclinical Testing Requirements 79 Adam Woolley and Jan Willem van der Laan 6.1 Introduction 79 6.2.1 Overview 82 6.3 Nonclinical Testing in the Support of Clinical Trials 86 6.4 Overview 96 7 South Africa 99 Fariza Feraoun and Malik Feraoun 7.1 Introduction 99 7.2 Country Information 100 7.3 The Regulatory Aspects 101 7.4 The Nonclinical Safety Assessment 109 7.5 Conclusion 114 8 Asia Pacific: China 117 Lijie Fu and Qingli Wang 8.1 Introduction 117 8.2 History of Drug Administration 118 8.3 The Provisions for Drug Registration 122 8.4 The SFDA 123 8.5 The SFDA Affiliated Organizations 123 8.6 General Registration Procedures 125 8.7 Pharmaceutical Application 125 8.8 Import Drug Application 127 8.9 Testing Guidelines and Safety Evaluation 129 8.10 GLP Compliance in China 131 8.11 Animal Welfare Requirements 133 9 Pharmaceutical Regulations for Nonclinical Safety Assessment in Japan 135 Kazuichi Nakamura and Osamu Fueki 9.1 History of Regulation for Nonclinical Safety Assessment in Japan 135 9.2 Approval Application of New Drugs in Japan 136 9.3 Current Nonclinical Safety Guidelines Available in Japan 139 9.4 Current Trends of Conduct of Nonclinical Safety Evaluation in Japan 139 9.5 Safety Assessment of Unapproved Drugs 142 9.6 Necessity of 3Rs (Reduction/Refinement/Replacement) of Animal Studies 142 9.7 Attitude of Japanese Pharmaceutical Companies and the Regulatory Agency toward Nonclinical Safety Assessment 142 10 Indian Regulatory Process for Nonclinical Drug Development 145 K.S. Rao and S. Natesan 10.1 Introduction 145 10.2 Drug Development 146 10.3 Quality Systems 147 10.4 Nonclinical Drug Development – Key Regulatory Requirements 148 10.5 Nonclinical Safety Assessment – Key Approval Requirements 149 10.6 Data Required for Clinical Study Approval 151 10.7 Animal Toxicology 154 10.8 Animal Pharmacology 166 10.9 Safety Assessment Requirements: Indian Schedule Yand International Guidelines 168 10.10 Good Laboratory Practice Quality System in India 168 10.11 Safety Assessment Test Facilities in India 171 10.12 Investigational New Drug Application for Undertaking Clinical Trials 173 11 Asia Pacific: Australia 175 Douglas Francis 11.1 Introduction 175 11.2 Australian Therapeutic Goods Administration (TGA) 176 11.3 Clinical Trials in Australia 183 11.4 Nonclinical Data to Support the Conduct of Clinical Trials in Australia and Marketing Application to the TGA 188 Part II Toxicology Studies Supporting Clinical Development 197 12 Repeated-Dose Toxicity Studies in Nonclinical Drug Development 199 Shana Azri-Meehan and Louise Latriano 12.1 Introduction 199 12.2 General Considerations 200 12.3 Study Design Considerations 205 12.4 Study Observations and Assessments 211 13 Evaluation of Potential Carcinogenicity 219 James A. Popp and Matthew S. Bogdanffy 13.1 Introduction 219 13.2 Preparation for the Carcinogenicity Study 223 13.3 Elements of the Protocol/Study Plan 228 13.4 Study Performance 241 13.5 Alternative Models to Evaluate Potential Carcinogenicity in Lieu of a 2-Year Mouse Study 244 13.6 Special Consideration for Carcinogenicity Evaluation of Biotherapeutics 247 13.7 Regulatory Implications of a Study Identifying an Animal Carcinogenic Response 248 13.8 Interpreting the Relevance of Positive Results for Human Safety 249 13.9 Communicating the Results in the Product Label 251 14 Genetic Toxicology 255 Mark W. Powley 14.1 Background 255 14.2 Regulations Guiding Drug Development 256 14.3 Genotoxic Impurities 261 14.4 Regulatory Decision Making 263 15 Developmental and Reproductive Toxicology 265 Robert M. Parker and Raymond G. York 15.1 Introduction 265 15.2 Standard Reproduction and Developmental Toxicity Study Designs 266 15.3 Timing of Preclinical Developmental and Reproductive Toxicity Studies 273 15.4 Based on Disease Indication 275 15.5 Based on Pharmaceutical Characteristic 279 15.6 Other Reasons to Conduct Preclinical Reproductive and Developmental Toxicity Studies 291 15.7 Excipients 293 15.8 Conclusion 293 16 Juvenile Animal Toxicity Studies: Regulatory Expectations, Decision Strategies and Role in Paediatric Drug Development 297 Melissa S. Tassinari, Luc M. De Schaepdrijver, and Mark E. Hurtt 16.1 Introduction 297 16.2 Regulatory Environment 298 16.3 Relevance and Place in Drug Development 302 16.4 Strategies for Decision Making: When are Studies Needed and Appropriate? 304 16.5 Case Studies: Application of Data Review and Decision Making 307 16.6 Summary 309 17 Immunotoxicology 313 Leigh Ann Burns-Naas and Marc J. Pallardy 17.1 Introduction 313 17.2 Regulatory Expectations for the Immunotoxicology Evaluation of Pharmaceuticals 314 17.3 Special Considerations 335 17.4 Summary 342 References 342 18 Nonclinical Safety Assessment: Biotechnology-Derived Pharmaceuticals 347 Christopher E. Ellis, Melanie T. Hartsough, Martin D. Green, and Hanan Ghantous 18.1 Introduction 347 18.2 Unique Characteristics of Biopharmaceuticals 348 18.3 Species Selection 349 18.4 Immunogenicity 356 18.5 Biological Activity/Pharmacodynamics 358 18.6 Pharmacokinetics/Toxicokinetics 359 18.7 Nonclinical Safety Assessment 362 18.8 Tissue Cross-Reactivity (TCR) 371 18.9 Clinical Starting Dose Selection for Biopharmaceuticals 373 18.10 Comparability 375 19 International Safety Regulations for Vaccine Development 381 Robert V. House 19.1 Introduction 381 19.2 What "Toxicities" have been Attributed to Vaccination? 381 19.3 How Vaccines are (Slightly) Different from Other Biopharmaceuticals 383 19.4 Regulatory Framework for Assessing Safety of Vaccines 383 19.5 Parameters Monitored 387 19.6 Clinical Safety Assessment of Vaccines 389 19.7 Summary 390 20 Phototoxicity and Photocarcinogenicity 393 Robert E. Osterberg, Christopher P. Sambuco, and Paul Donald Forbes 20.1 History of Phototoxicity, Photocarcinogenicity and Photogenotoxicity Testing at the US Food and Drug Administration (FDA) 393 20.2 FDA Photosafety Testing Guidance 397 20.3 Status of In Vivo Testing for Photocarcinogenesis 417 20.4 Photocarcinogenesis Study Designs 418 20.5 Photo Co-Carcinogenesis 418 20.6 Future Testing Concepts, with Emphasis on Biomarkers 423 21 Degradants, Impurities, Excipients and Metabolites 431 Robert E. Osterberg and Mark W. Powley 21.1 Degradants, Impurities, and Excipients 431 21.2 Metabolites 442 References 446 Index 449

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Book SynopsisWith continued discoveries and innovations, the field of materials synthesis and processing remains as it has been for many decades, a vibrant and fertile area for research and development.Table of ContentsPreface ix Introduction xi SYNTHESIS AND PROCESSING BY THE SPARK PLASMA METHOD Simulation of Contact Resistances Influence on Temperature Distribution during SPS Experiments 3 A. Cincotti, A. M. Locci, R. Orrù, and G. Cao Spark-Plasma-Sintering (SPS) Processsing of High Strength Transparent MgAI204 Spinel Polycrystals 19 Koji Morita, Byung-Nam Kim, Hidehiro Yoshida, and Keijiro Hiraga Consolidation of Carbon with Amorphous-Graphite Transformation by SPS 31 Naoki Toyofuku, Megumi Nishimoto, Kazuki Arayama, Yasuhiro Kodera, Manshi Ohyanagi, and Zuhair A. Munir Spark Plasma Sintering of Nanostructured Ceramic Materials with Potential Magnetoelectricity 41 C. Correas, R. Jiménez, T. Hungría, H. Amorin, J. Ricote, E. Vila, M. Algueró, A. Castro, and J. Galy Sintering and Properties of Nanometric Functional Oxides 55 Dat V. Quach, Sangtae Kim, Manfred Martin, and Zuhair A. Munir Spark Plasma Sintering Mechanisms in Si3N4-Based Materials 63 M. Belmonte, J. Gonzalez-Julian, P. Miranzo, and M.I. Osendi Consolidation of SiC with BN through MA-SPS Method 71 Yasuhiro Kodera, Naoki Toyofuku, Ryousuke Shirai, Manshi Ohyanagi, and Zuhair A. Munir Fabrication of Dense Zr-, Hf- and Ta-Based Ultra High Temperature Ceramics by Combining Self-Propagating High-Temperature Synthesis and Spark Plasma Sintering 81 Roberta Licheri, Roberto Orrù, Clara Musa, Antonio Mario Locci, and Giacomo Cao NOVEL, GREEN, AND STRATEGIC PROCESSING Microwave Sintering of Mullite and Mullite-Zirconia Composites 95 Subhadip Bodhak, Susmita Bose, and Amit Bandyopadhyay Idle Time and Gelation Behavior in Gelcasting Process of PSZ in Acrylamide System 105 Nasim Sahraei Khanghah and Mohammad-Ali Faghihi-Sani Characterization of the Mesoporous Amorphous Silica in the Fresh Water Sponge Cauxi 115 Ralf Keding, Martin Jensen, and Yuanzheng Yue Novel Chemistry-Modification Approach for Synthesis of SiAION from Fly Ash 131 J. P. Kelly, J. R. Varner, W. M. Carty, and V. R. Amarakoon Patterning of Closed Pores Utilizing the Superplastically Foaming Method 143 A. Kishimoto, Y. Nishino, and H. Hayashi The Research of Materials Life Cycle Assessment 153 ZuoRen Nie, Feng Gao, XianZheng Gong, ZhiHong Wang, and TieYong Zuo Modeling Dual and MgO Saturated EAF Slag Chemistry 167 Kyei-Sing Kwong, James Bennett, Rick Krabbe, Art Petty, and Hugh Thomas ADVANCED POWDER PROCESSING Aqueous Processing of TiC Preforms for Advanced Cermet Preparation 181 R. Bradley Collier and Kevin P. Plucknet The Effect of Precipitator Types on the Synthesis of La2Zr207 Powders by Chemical Coprecipitation Method 189 Jing Wang, Shuxin Bai, Hong Zhang, and Changrui Zhang The Study of Prepration of Blue V-Zircon Pigment by Using Zircon and Sulphuric Acid 197 M. Riahi and M.A. Faghihi Sani Preparation of Blue-Ceramic Pigments by Reaction Bonding 207 Enrique Rocha-Rangel, Imelda Villanueva-Baltazar, Lucia Téllez-Jurado, and Elizabeth Refugio-García Colloidal Characterization and Aqueous Gel Casting of Barium Titanate Ceramics 215 Cameron D. Munro and Kevin P. Plucknett Dispersion and Fluidity of Aqueous Aluminium Titanate Slurry by Addition of Titanate Aqueous Solution 227 Seizo Obata, Yoshiyuki Iwata, Hisanori Yokoyama, Osamu Sakurada, Minoru Hashiba, and Yasutaka Takahashi Author Index 235

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