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Argument Writing, Teacher Guide, Grades 9-12

Argument Writing, Teacher Guide, Grades 9-12

PCG Education

ISBN: 978-1-119-22964-3

Jun 2016, Jossey-Bass

312 pages

$32.95

Description

Paths to College and Career

Jossey-Bass and PCG Education 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.

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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