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Argument Writing, Teacher Guide, Grades 9-12

1. Aufl.

von: PCG Education
21,99 €
Verlag:	Wiley
Format:	EPUB
Veröffentl.:	07.06.2016
ISBN/EAN:	9781119229643
Sprache:	englisch
Anzahl Seiten:	304

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Titelbeschreibung

Argument Writing Paths to College and Career Jossey-Bass and Public Consulting Group, Inc. (PCG) are proud to bring the Paths to College and Career English Language Arts (ELA) curriculum and professional development resources for grades 6–12 to educators across the country. Originally developed for EngageNY and written with a focus on the shifts in instructional practice and student experiences the standards require, Paths to College and Career includes daily lesson plans, guiding questions, recommended texts, scaffolding strategies and other classroom resources. The Paths Writing Units, Argument Writing, Informative Writing, and Narrative Writing, complement the full instructional program and can also be used independently, providing in-depth writing instruction to support all students in grades 9–12 in meeting grade level standards. To emphasize the relationship between reading and writing, each Writing Unit includes accessible model texts that exemplify key elements of each text type, and source texts that provide a topic for the unit writing assignment. Individual lessons guide students through the writing process, providing instruction on grammar and conventions and highlighting collaboration and reflection as key elements of effective writing. Students' final essays are assessed using a checklist developed by the class over the course of the unit. The organization and distinctive content of the model and source texts in each unit afford teachers the flexibility to implement each unit independently of the others, and at any point during the curriculum. For example, a unit may be implemented to assess students' writing prior to implementation of the standard curriculum, to scaffold writing instruction leading into a writing assessment, or to support struggling writers by addressing gaps in skills as demonstrated in previous assessments. The Paths Writing Units provide teachers with invaluable opportunities to engage students as active participants in their own learning at every stage of the writing process, and to customize instruction to meet the varying needs of all students. ABOUT PUBLIC CONSULTING GROUP Public Consulting Group, works with schools, districts, and state education agencies to build their capacity for instructional and programmatic improvements. We provide curriculum development, coaching, professional development, and technical assistance services. Our work alongside educators and policy makers ensures effective implementation of both the Common Core State Standards and state-specific standards for college and career readiness. As the creators of the Paths ELA curriculum for grades 6–12, Public Consulting Group provides a professional learning program that ensures the success of the curriculum. The program includes: <ul> <li>Nationally recognized professional development from an organization that has been immersed in the new standards since their inception.</li> <li>Blended learning experiences for teachers and leaders that enrich and extend the learning.</li> <li>A train-the-trainer program that builds capacity and provides resources and individual support for embedded leaders and coaches.</li> </ul>

Inhaltsverzeichnis

PREFACE xxv ABOUT THE AUTHOR xxvii 1 The Drug Development Process and the Global Pharmaceutical Marketplace 1 1.1 Introduction, 1 1.2 The Marketplace, 1 1.3 History of Modern Therapeutics, 4 1.4 The Drug Development Process, 6 1.5 Strategies for Development: Large Versus Small Company or the Short Versus Long Game, 7 1.6 Safety Assessment and the Evolution of Drug Safety, 11 1.7 The Three Stages of Drug Safety Evaluation in the General Case, 11 References, 12 2 Regulation of Human Pharmaceutical Safety: Routes to Human Use and Market 13 2.1 Introduction, 13 2.2 Brief History of US Pharmaceutical Law, 13 2.3 FDAMA Summary: Consequences and Other Regulations, 19 2.4 Overview of US Regulations, 21 2.5 Organizations Regulating Drug and Device Safety in the United States, 24 2.6 Process of Pharmaceutical Product Development and Approval, 25 2.8 Toxicity/Safety Testing: Cellular and Gene Therapy Products, 33 2.9 Toxicity Testing: Special Cases, 35 2.10 International Pharmaceutical Regulation and Registration, 41 2.11 Combination Products, 50 2.12 Conclusions, 55 References, 55 Further Reading, 57 3 Data Mining: Sources of Information for Consideration in Study and Program Design and in Safety Evaluation 59 3.1 Introduction, 59 3.2 PC‐Based Information Products: Laser DISC, 65 3.3 Conclusions, 65 References, 65 4 Screens in Safety and Hazard Assessment 67 4.1 Introduction, 67 4.2 Characteristics of Screens, 68 4.3 Uses of Screens, 70 4.4 Types of Screens, 71 4.5 Criterion: Development and Use, 71 4.6 Analysis of Screening Data, 73 4.7 Univariate Data, 73 References, 76 5 Formulations, Routes, and Dosage Regimens 79 5.1 Mechanisms, 81 5.2 Common Routes, 83 5.3 Formulation of Test Materials, 96 5.4 Dosing Calculations, 105 5.5 Calculating Material Requirements, 105 5.6 Excipients, 106 References, 111 6 Nonclinical Manifestations, Mechanisms, and End Points of Drug Toxicity 115 6.1 Manifestations, 115 6.2 Mechanisms of Toxicity, 116 6.3 End Points Measured in General Toxicity Studies, 116 6.4 Complications, 126 References, 126 7 Pilot Toxicity Testing in Drug Safety Evaluation: MTD and DRF 129 7.1 Introduction, 129 7.2 Range‐Finding Studies, 130 7.3 Acute Systemic Toxicity Characterization, 138 7.4 Screens, 150 7.5 PILOT and DRF Studies, 154 References, 156 8 Repeat‐Dose Toxicity Studies 159 8.1 Objectives, 159 8.2 Regulatory Considerations, 161 8.3 Study Design and Conduct, 162 8.4 Study Interpretation and Reporting, 165 References, 166 9 Genotoxicity 169 9.1 ICH Test Profile, 169 9.2 DNA Structure, 169 9.3 Cytogenetics, 176 9.4 In Vitro Cytogenetic Assays, 193 9.5 In Vivo Cytogenetic Assays, 196 9.6 Sister Chromatid Exchange Assays, 197 References, 199 10 QSAR Tools for Drug Safety 209 10.1 Structure–Activity Relationships, 209 10.2 SAR Modeling Methods, 210 10.3 Applications in Toxicology, 212 10.4 Genotoxicity, 215 10.5 Comparison of Available Models/Applications, 216 References, 222 11 Immunotoxicology in Drug Development 225 11.1 Introduction, 225 11.2 Overview of the Immune System, 227 11.3 Immunotoxic Effects, 229 11.4 Immunosuppression, 231 11.5 Immunostimulation, 235 11.6 Regulatory Positions, 240 11.7 Evaluation of the Immune System, 245 11.8 Nonspecific Immunity Function Assay, 251 11.9 T‐Cell‐Dependent Antibody Response (TDAR), 253 11.10 Approaches to Compound Evaluation, 259 11.11 Problems and Future Directions, 263 References, 264 12 Nonrodent Animal Studies 269 12.1 Introduction, 269 12.2 Comparison Between Rodent and Nonrodent Experimental Design, 269 12.3 Differences in Study Activities, 270 12.4 Nonrodent Models, 270 12.5 Dog, 270 12.6 The Ferret, 273 12.7 The Pig, 275 12.8 Nonhuman Primates, 279 12.9 Statistics in Large Animal Studies, 283 12.10 Summary, 288 References, 288 13 Developmental and Reproductive Toxicity Testing 291 13.1 Introduction, 291 13.2 ICH Study Designs, 293 13.3 Methodological Issues, 298 13.4 Developmental Studies in Primates, 303 13.5 Data Interpretation, 304 13.6 Juvenile and Pediatric Toxicology, 310 13.7 In Vitro Tests for Developmental Toxicity, 312 13.8 Appraisal of Current Approaches for Determining Developmental and Reproductive Hazards, 316 References, 317 14 Carcinogenicity Studies 321 14.1 Introduction, 321 14.2 Mechanisms and Classes of Carcinogens, 322 14.3 Genotoxic Carcinogens, 322 14.4 Epigenetic Carcinogens, 325 14.5 Regulatory Requirements and Timing, 328 14.6 Species and Strain, 328 14.7 Animal Husbandry, 330 14.8 Dose Selection, 330 14.9 Group Size, 331 14.10 Route of Administration, 332 14.11 Study Duration, 332 14.12 Survival, 332 14.13 End Points Measured, 333 14.14 Transgenic Mouse Models, 335 14.15 Interpretation of Results: Criteria for a Positive Result, 338 14.16 Statistical Analysis, 338 14.17 Weight‐of‐Evidence Factors for Consideration in a Carcinogenicity Assessment Document (CAD), 344 14.18 Conclusions, 345 References, 345 15 Histopathology in Nonclinical Pharmaceutical Safety Assessment 351 15.1 Introduction, 351 15.2 Clinical Pathology, 355 References, 356 16 Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment 359 16.1 Introduction, 359 16.2 Factors Affecting Irritation Responses and Test Outcome, 359 16.3 Primary Dermal Irritation (PDI) Test, 360 16.4 Other Nonparenteral Route Irritation Tests, 362 16.5 Ocular Irritation Testing, 362 16.6 Vaginal Irritation, 364 16.7 Acute Primary Vaginal Irritation Study in the Female Rabbit, 365 16.8 Parenteral Irritation/Tolerance, 367 16.9 Problems in Testing (and Their Resolutions), 370 16.10 Phototoxicity, 371 16.11 Hemocompatibility, 377 References, 378 17 Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation 381 17.1 Introduction, 381 17.2 Regulations, 382 17.3 Principles, 382 17.4 Pharmacokinetics, 395 17.5 Laboratory Methods, 395 17.6 Sampling Methods and Intervals, 397 17.7 Study Types, 400 17.8 Analysis of Data, 402 17.9 Physiologically Based Pharmacokinetic (PBPK) Modeling, 404 17.10 Points to Consider, 405 17.11 Biologically Derived Materials, 406 17.12 Points to Consider, 410 References, 410 18 Safety Pharmacology 413 18.1 Regulatory Requirements, 414 18.2 Study Designs and Principles, 415 18.3 Organ System‐Specific Tests, 416 18.4 Cardiovascular, 416 18.5 Central Nervous System, 419 18.6 Respiratory/Pulmonary System, 422 18.7 Secondary Organ System, 427 18.8 Renal Function Tests, 428 18.9 Summary, 428 References, 428 19 Special Concerns for the Preclinical Evaluation of Biotechnology Products 433 19.1 Regulation, 436 19.2 Preclinical Safety Assessment, 437 19.3 Recombinant DNA Technology, 439 19.4 Immunogenicity/Allergenicity, 440 19.5 Monoclonal Antibody Technology, 441 19.6 Bioprocess Technology, 446 19.7 Gene Therapy Products, 446 19.8 Vaccines, 449 19.9 Special Challenges, 452 19.10 Planning a Safety Evaluation Program, 454 19.11 Challenges: Biosimilars, 458 References, 459 20 Safety Assessment of Inhalant Drugs and Dermal Route Drugs 461 20.1 Inhaled Therapeutics, 461 20.2 The Pulmonary System, 461 20.3 Penetration and Absorption of Inhaled Gases and Vapors, 462 20.4 Deposition of Inhaled Aerosols, 463 20.5 Absorption and Clearance of Inhaled Aerosols, 464 20.6 Pharmacokinetics and Pharmacodynamics of Inhaled Aerosols, 464 20.7 Methods for Safety Assessment of Inhaled Therapeutics, 465 20.8 Parameters of Toxicity Evaluation, 467 20.9 Inhalation Exposure Techniques, 470 20.10 The Utility of Toxicity Data, 473 20.11 Formulation and Potential Mucosal Damage, 473 20.12 Therapeutic Drug Delivery by the Dermal Route, 474 References, 476 21 Special Case Products: Imaging Agents 483 21.1 Introduction, 483 21.2 Imaging Agents, 483 References, 487 22 Special Case Products: Drugs for Treatment of Cancer 489 22.1 Introduction, 489 References, 493 23 Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile Toxicology) 495 23.1 Introduction, 495 23.2 Issues to Consider Regarding Juvenile Animal Studies, 498 23.3 General Considerations in Designing Toxicity Studies in Juvenile Animals, 499 23.4 Study Designs and Considerations, 500 References, 501 24 Use of Imaging, Imaging Agents, and Radiopharmaceuticals in Nonclinical Toxicology 503 24.1 Introduction, 503 24.2 X‐ray, 505 24.3 Positron Emission Tomography (PET), 505 24.4 Single‐photon Emission Computed Tomography (SPECT), 505 24.5 Computed Tomography (CT), 506 24.6 Magnetic Resonance Imaging (MRI), 506 24.7 Optical Imaging, 507 24.8 Ultrasound, 508 24.9 Nanoparticle Contrast Agents, 509 24.10 Radiopharmaceuticals, 509 24.11 Applications of Preclinical Imaging in Laboratory Animals, 509 24.12 Nonclinical Safety Assessment for Imaging Agents, 515 24.13 Radiopharmaceuticals, 517 24.14 Nonclinical Late Radiation Toxicity Studies, 519 24.15 Study Design, 519 References, 520 25 Occupational Toxicology in the Pharmaceutical Industry 523 25.1 Introduction, 523 25.2 Occupational Toxicology versus Drug Safety Evaluation, 523 25.3 Regulatory Pressures in the United States and the European Community, 525 25.4 Organizational Structure, 526 25.5 Activities, 527 25.6 Conclusion, 534 References, 534 26 Strategy and Phasing for Nonclinical Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals 537 26.1 Introduction, 537 26.2 Regulatory Requirements, 539 26.3 Essential Elements of Project Management, 542 26.4 Screens: Their Use and Interpretation in Safety Assessment, 544 26.5 Strategy and Phasing, 546 26.6 Critical Considerations, 550 26.7 Special Cases in Safety Assessment, 551 26.8 Summary, 551 References, 551 27 The Application of In Vitro Techniques in Drug Safety Assessment 553 27.1 Introduction, 553 27.2 In Vitro Testing in Pharmaceutical Safety Assessment, 555 27.3 Defining Testing Objective, 558 27.4 Test Systems: Characteristics, Development, and Selection, 558 27.5 In Vitro Models, 559 27.6 Lethality, 560 27.7 In Silico Methods, 572 27.8 The Final Frontier and Barrier: Regulatory Acceptance, 573 27.9 Summary, 573 References, 575 Further Reading, 581 28 Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond 583 28.1 The Pharmaceutical Clinical Development Process and Safety, 583 28.1.1 Pharmacokinetics, 589 28.1.2 Safety of Clinical Trial Subjects, 591 28.2 Limitations on/of Clinical Trials, 598 28.3 The Clinical Trial Process, 598 28.4 Institutional Review Boards (IRBS)/Ethics Committees in the Clinical Trial Process, 602 28.5 Drug Formulations and Excipients, 604 28.6 Phase I Designs, 605 28.7 Clinical Trial Safety Indicators, 609 28.8 Assessment of Unwanted Drug Effects, 621 References, 626 29 Postmarketing Safety Evaluation : Monitoring, Assessing, and Reporting of Adverse Drug Responses (ADRs) 629 29.1 Causes of Safety Withdrawals, 637 29.2 Regulatory Requirements, 638 29.3 Management of ADR and ADE Data, 641 29.4 Causality Assessment, 647 29.5 Courses of Corrective Action, 647 29.6 Legal Consequences of Safety Withdrawal, 648 References, 651 30 Statistics in Pharmaceutical Safety Assessment 653 30.1 Introduction, 653 30.2 Experimental Design, 659 30.3 Data Recording, 664 30.4 Generalized Methodology Selection, 665 30.5 Statistical Analysis: General Considerations, 665 30.6 Hypothesis Testing of Categorical and Ranked Data, 679 30.7 Hypothesis Testing: Univariate Parametric Tests, 684 30.8 Methods for the Reduction of Dimensionality, 694 30.9 Meta‐Analysis, 701 30.10 Bayesian Inference, 702 30.11 Data Analysis Applications in Safety Assessment Studies, 704 References, 708 31 Combination Products: Drugs and Devices 711 31.1 Combination Products, 711 References, 720 32 Qualification of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals 721 32.1 Impurities, 721 32.2 Residual Solvents, 726 32.3 Extractables and Leachables, 727 32.4 Residual Metals and Elements, 728 References, 730 33 Tissue, Cell, and Gene Therapy 731 33.1 Safety Assessment of Cell Therapy (CT) Products, 732 33.2 Nonclinical Safety Assessment of Gene Therapy Products (GTPS), 738 33.3 Definitions, 741 References, 742 Appendix A: Selected Regulatory and Toxicological Acronyms 743 Appendix B: Definition of Terms and Lexicon of “Clinical” Observations in Nonclinical (Animal) Studies 745 Appendix C: Notable Regulatory Internet Addresses 749 Appendix D: Glossary of Terms Used in the Clinical Evaluation of Therapeutic Agents 755 Appendix E: Common Vehicles for the Nonclinical Evaluation of Therapeutic Agents 759 Appendix F: Global Directory of Contract Pharmaceutical Toxicology Labs 857 INDEX 879

Autorenportrait

ABOUT PCG EDUCATION PCG Education, a division of Public Consulting Group, works with schools, districts, and state education agencies to build their capacity for instructional and programmatic improvements. We provide curriculum development, coaching, professional development, and technical assistance services. Our work alongside educators and policy makers ensures effective implementation of both the Common Core State Standards and state-specific standards for college and career readiness. As the creators of the Paths ELA curriculum for grades 6–12, PCG Education provides a professional learning program that ensures the success of the curriculum. The program includes: <ul> <li>Nationally recognized professional development from an organization that has been immersed in the new standards since their inception.</li> <li>Blended learning experiences for teachers and leaders that enrich and extend the learning.</li> <li>A train-the-trainer program that builds capacity and provides resources and individual support for embedded leaders and coaches.</li> </ul>