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Drug Safety Data

Drug Safety Data

Author: Michael J. Klepper

Publisher: Jones & Bartlett Learning

ISBN: 0763769126

Category: Medical

Page: 312

View: 852

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Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk

Author: Michael J. Klepper

Publisher: Jones & Bartlett Publishers

ISBN: 9781449671556

Category: Medical

Page: 316

View: 915

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Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Drug Information: A Guide for Pharmacists, 7th Edition

Drug Information: A Guide for Pharmacists, 7th Edition

Author: Patrick M. Malone

Publisher: McGraw Hill Professional

ISBN: 9781260460315

Category: Medical

Page: 912

View: 445

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Everything pharmacists and pharmacy students need to know about drug information management Drug Information: A Guide for Pharmacists provides you with the tools you need to to research, interpret, evaluate, collate, and disseminate drug information in the most effective and efficient manner possible. This trusted resource addresses essential topics such as formulating an effective response and recommendations for information, evaluation of drug literature, the application of statistical analysis in the biomedical sciences, medications and patient safety, investigational drugs, and more. This updated seventh edition also addresses other important issues such as the legal and ethical considerations of providing information, how to respond to requests for information, and how to determine what information should be made available.

The Fundamentals of Clinical Research

The Fundamentals of Clinical Research

Author: P. Michael Dubinsky

Publisher: John Wiley & Sons

ISBN: 9781118949597

Category: Medical

Page: 554

View: 176

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This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

Indoor Air Quality Handbook

Indoor Air Quality Handbook

Author: John D. Spengler

Publisher: McGraw Hill Professional

ISBN: 9780071414845

Category: Technology & Engineering

Page: 1675

View: 498

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* Tackles the complex environmental issue of Indoor Air Quality (IAQ) for industrial hygienists, HVAC engineers, architects and anyone else concerned with the air quality of interiors * Infused with charts, tables, and all the major formulas and calculations necessary to monitor and characterize a particular environment * Includes all relevant codes, standards and guidelines

Statistical Methods

Statistical Methods

Author: National Research Council (U.S.). Transportation Research Board

Publisher:

ISBN: UCLA:L0098571508

Category: Motor vehicle occupants

Page: 254

View: 289

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This Transportation Research Record contains 28 papers dealing with statistical methods in highway safety research; highway safety data, analysis, and evaluation; occupant protection; and systematic reviews and meta-analysis. The papers address such topics as risk and crash prediction models, crashes on freeways and at signalized intersections, multivehicle crash prediction, speed and safety, red light running crashes, freeway lane closures, ramp design, accident exposure, rumble strip benefits, collisions with median trees, intersection safety, accident reconstruction, safety effects of speed limit changes, geometric design and head-on crashes, deer-vehicle crashes, sport utility vehicle rollover, vehicle occupancy and crash risk, a logit model for studying injury severity, abdominal injuries in rail passengers, healthy transport policies, and meta-analysis.

Lewis's Medical-Surgical Nursing E-Book

Lewis's Medical-Surgical Nursing E-Book

Author: Mariann M. Harding

Publisher: Elsevier Health Sciences

ISBN: 9780323792325

Category: Medical

Page: 1829

View: 846

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Gain the knowledge and skills you need to succeed in medical-surgical nursing with this leading textbook! Lewis's Medical-Surgical Nursing, 12th Edition uses a conversational writing style, a focus on nursing concepts and clinical trends, evidence-based content, and basic pathophysiology review to provide the solid foundation needed in a rapidly changing healthcare environment. Comprehensive chapters cover topics including nursing management and collaboration, health promotion, acute interventions, and ambulatory care. Summary tables and boxes make it easy to find essential information, and a building-block approach makes even the most complex concepts simple to grasp. In addition to three new chapters, this edition includes a stronger focus on the nursing process, clinical judgment, and preparation for the Next-Generation NCLEX® Examination. Content written and reviewed by leading experts in the field ensures that information is comprehensive, current, and clinically accurate. Interprofessional care is addressed in special Interprofessional Care sections and Interprofessional Care tables. Bridge to the NCLEX® Examination review questions reinforce key content and include both standard and alternate item format questions to help you prepare for the NCLEX exam. Coverage of cultural and ethnic health disparities highlights important issues such as risk factors, economic aspects, and access to health care. Coverage of gerontology and chronic illness is addressed in a separate chapter and highlighted in special gerontologic tables. Pathophysiology maps use flowcharts to outline complex concepts related to diseases, making them easier to understand. Focused Assessment boxes provide brief checklists for a practical "assessment on the run" or bedside approach to assessment, and can be used to evaluate the status of previously identified health problems and monitor for signs of new problems. Safety Alert boxes highlight patient safety issues and focus on the National Patient Safety Goals. Nutritional Therapy tables summarize nutritional interventions and strategies for promoting healthy lifestyles. Promoting Population Health boxes summarize health care goals as they relate to specific disorders such as cancer and diabetes, and identify strategies for health promotion. Drug Therapy tables and Drug Alerts highlight important safety considerations for key drugs. Check Your Practice boxes challenge you to think critically, analyze patient assessment data, and implement appropriate interventions. Coverage of genetics includes a separate chapter on genetics, Genetics in Clinical Practice boxes covering disorders and genetic testing, risk alerts, and links to disorders. Focus on patient and caregiver teaching shows how you can help patients and caregivers learn to manage chronic illnesses and conditions. Ethical / Legal Dilemmas boxes introduce key topics such as informed consent, advance directives, and confidentiality.

Lewis's Medical-Surgical Nursing - 2-Volume Set

Lewis's Medical-Surgical Nursing - 2-Volume Set

Author: Mariann M. Harding

Publisher: Mosby

ISBN: 0323792421

Category: Medical

Page: 0

View: 194

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Gain the knowledge and skills you need to succeed in medical-surgical nursing with this leading textbook! Lewis''s Medical-Surgical Nursing, 12th Edition uses a conversational writing style, a focus on nursing concepts and clinical trends, evidence-based content, and basic pathophysiology review to provide the solid foundation needed in a rapidly changing healthcare environment. Comprehensive chapters cover topics including nursing management and collaboration, health promotion, acute interventions, and ambulatory care. Summary tables and boxes make it easy to find essential information, and a building-block approach makes even the most complex concepts simple to grasp. In addition to three new chapters, this edition includes a stronger focus on the nursing process, clinical judgment, and preparation for the Next-Generation NCLEX® Examination. Content written and reviewed by leading experts in the field ensures that information is comprehensive, current, and clinically accurate. Interprofessional care is addressed in special Interprofessional Care sections and Interprofessional Care tables. Bridge to the NCLEX® Examination review questions reinforce key content and include both standard and alternate item format questions to help you prepare for the NCLEX exam. Coverage of cultural and ethnic health disparities highlights important issues such as risk factors, economic aspects, and access to health care. Coverage of gerontology and chronic illness is addressed in a separate chapter and highlighted in special gerontologic tables. Pathophysiology maps use flowcharts to outline complex concepts related to diseases, making them easier to understand. Focused Assessment boxes provide brief checklists for a practical "assessment on the run" or bedside approach to assessment, and can be used to evaluate the status of previously identified health problems and monitor for signs of new problems. Safety Alert boxes highlight patient safety issues and focus on the National Patient Safety Goals. Nutritional Therapy tables summarize nutritional interventions and strategies for promoting healthy lifestyles. Promoting Population Health boxes summarize health care goals as they relate to specific disorders such as cancer and diabetes, and identify strategies for health promotion. Drug Therapy tables and Drug Alerts highlight important safety considerations for key drugs. Check Your Practice boxes challenge you to think critically, analyze patient assessment data, and implement appropriate interventions. Coverage of genetics includes a separate chapter on genetics, Genetics in Clinical Practice boxes covering disorders and genetic testing, risk alerts, and links to disorders. Focus on patient and caregiver teaching shows how you can help patients and caregivers learn to manage chronic illnesses and conditions. Ethical / Legal Dilemmas boxes introduce key topics such as informed consent, advance directives, and confidentiality. Enhanced focus on clinical judgment and preparation for the Next-Generation NCLEX® Exam (NGN) features Applying Clinical Judgment With Multiple Patients boxes with traditional and NGN-style questions. Revised table of contents reflects critical care content throughout the book and adds new chapters including Supporting Ventilation and Caring for Lesbian, Gay, Bisexual, Transgender, Queer or Questioning, and Gender Diverse Patients. Social Determinants of Health chapter focuses on nursing awareness of how patient circumstances affect health outcomes. Clinical problems language replaces NANDA-I / ICNP diagnoses and better aligns with Harding & Hagler''s Conceptual Nursing Care Planning. Case studies - now labeled with Cognitive Skills from the NCSBN''s Clinical Judgment Measurement Model - bring patient care to life, helping you develop skills in clinical judgment, prioritization, delegation, and evidence-based practice. Conceptual focus for the patient experiencing infection or inflammation is included in the Infection chapter and the Inflammation and Healing chapter. Updated content throughout reflects the latest evidence-based guidelines for patient care. Streamlined features and content provide an optimized learning experience.