Bøger udgivet af PHARMALOGIKA

After surgery, it is essential to track your level of pain and your progress through physical therapy. Receiving appropriate treatment for any medical condition requires providing complete and accurate information to your medical team. This book has been designed to collect comprehensive information tracking the process of healing after surgery with successful pain management. The needs of the patient, the clinician, and the many supportive members of the medical team (including the patient's family) are balanced to provide an easy reference tool with precise results. Each page provides a unique hourly and daily graphical view of your pain scale with exact locations, therapeutic treatments, sleep patterns, exercise and activity levels, physical therapy regimens, physiological patterns and changes, and specific drug reactions. This graphical interface design documents your pain in a way that is familiar to your medical team so they can quickly recognize patterns and devise an effective treatment plan that will adequately treat your pain. Each data set provides a graphical snapshot of critical data and factors related to the many causes of pain, trends over time and treatment effectiveness. It is an invaluable communication tool between the patient and medical team that leads to faster solutions for effective treatment and better treatment compliance for the patient. Additionally, sections are provided for you to record some general medical history information to make certain you have everything in one place when you need it. Included Documents and Features: - Examples for completing each set of data records - Comprehensive personal and family medical history section detailing contributing health conditions and possible inherited traits - Monthly data summaries for easy long term trend analysis - Daily data records condensing critical information for diagnostic and treatment evaluation and trend analysis

Receiving appropriate treatment for any medical condition requires providing complete and accurate information to your medical team. Often, it will require more than one visit to more than one medical professional. Each visit requires completing similar forms and each of those professionals will likely ask many of the same questions, but with a slightly different focus. This book has been designed and tested to help shorten the frequently long and arduous process of diagnosing and successfully managing pain. The needs of the patient, the clinician, and the many supportive members of the medical team (including the patient's family) are perfectly balanced. This book is modeled on the principles of good clinical practices and patient questionnaire requirements for clinical study protocols. Each page provides a graphic snapshot of critical data and factors related to the many causes of pain, trends over time and treatment effectiveness. It is an invaluable communication tool between the patient and medical team that leads to faster solutions for effective treatment and better treatment compliance for the patient. Included Documents and Features: - Examples for completing each set of data records - Comprehensive personal and family medical history section detailing contributing health conditions and possible inherited traits - Monthly data summaries for easy long term trend analysis - Daily data records condensing critical information for diagnostic and treatment evaluation and trend analysis

Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a refresher. While the specific regulations and requirements may differ widely between pharmaceutical, biotechnology, medical device, and food manufacturers, the inspection processes and procedures do not.

This book includes both Hospital Corpsman NAVEDTRA 14295 and the Advancement Handbook for Hospital Corpsman. The United States Navy training programs have long been the standard used as the pinnacle of training achievement. The Hospital Corpsman training program has been continuously tested and updated to successfully educate every member of the Navy Hospital Corps since its inception. The needs of the instructor, the student, the patient, and the Navy are perfectly balanced. This is the model all educators should follow when developing training programs.

Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic: * FDA Overview and Orientation * Introduction to GCP * Part I: General * Part II: Institutional Review Boards (IRBs) and Informed Consent * Part III: Drugs and Biologics * Part IV: Medical Devices * Part V: Manufacturing Requirements for Investigational Products * Part VI: Electronic Data Reference Tools * Part VII: Combined Glossary and Index for all Quality Guidance Documents

This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.

Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections * Investigational Drug Accountability, Administration, and Labeling

ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability [Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation [Q2(R1)] * Part III: Impurities [Q3A(R2), Q3B(R2), Q3C(R4)] * Part IV: Pharmacopoeias (List Overview) * Part V: Quality of Biotechnological Products [Q5A(R1), Q5B, Q5C, Q5D, Q5E] * Part VI: Specifications [Q6A, Q6B] * Part VII: Good Manufacturing Practice [Q7] * Part VIII: Pharmaceutical Development [Q8(R2)] * Part IX: Quality Risk Management [Q9] * Part X: Pharmaceutical Quality System [Q10] Reference Tools * Part XI: Questions and Answers for Q8/9/10 Quality Guidance Documents * Part XII: Combined Glossary and Index for all Quality Guidance Documents

Part I: Food and Drugs Act - Part A: Administration - Part C: Drugs Division 1 - Division 1A: Establishment Licences - Division 2: Good Manufacturing Practices Part II: Guidance Documents Part III: Annexes to the Current Edition of the Good Manufacturing Practices (GMP) Guidelines Part IV: Questions and Answers Part V: International Conference on Harmonisation (ICH) Guidance Documents - ICH Q1A(R2): Stability Testing of New Drug Substances and Products - ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products - ICH Q1C: Stability Testing for New Dosage Forms - ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology - ICH Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - ICH Q9: Quality Risk Management, Part VI: Compliance Policies Part VII: Forms Part VIII: Extensive Index

The United States Navy Basic Military Requirements have long been the standard used as the pinnacle of training achievement. This manual has been continuously tested and updated to successfully educate every member of the Navy since its inception. The needs of the instructor, the student, and the Navy are perfectly balanced. Whether you are planning to join the Navy, have served in the Navy, or plan to use the BMR as a template for training material development, this book is for you. This is the model all educators should follow when developing training programs and course materials.

The materials combined in this book provide complete, easily understandable, and well-planned learning tools for both military and civilian students. This Field Training Workbook is used as a quick reference manual for supportive care as well as guidance for the total skills competency required of medical personnel. In addition to providing the most concise information for consistent training and efficient learning, this text also provides guidance for diagnostics and self-testing. The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition of pioneering training systems that then transition into the corporate civilian sector. This manual has been continuously tested and updated to successfully educate every member of the modern United States Army Medical Department (AMEDD). Included Documents and Features: Supportive Care 1: - Treat Metabolic Endocrine Symptoms - Treat Neurological Symptoms - Treat Cardiopulmonary Symptoms - Treat Gastrointestinal Symptoms - Treat Genitourinary Symptoms - Treat Skin Disorders - Treat infectious Disease & Immunologic Symptoms - Competency Skill Sheets Supportive Care 2: - Manage a Seizing Casualty - Assist in Vaginal Delivery - Perform Medical Screening - Immunization and Chemoprophylaxis - Specimen Collection - Blood Draw - Competency Skill Sheets Supportive Care 3: - Basic Nursing Assessment - Nursing Documentation - Medication Administration - Pain Assessment and Management - Pharmacology for the Soldier Medic Supportive Care 4: - Post-Mortem Care - Wound Care - Perform Respiratory Care - Cardiac Monitoring - Chest Tube Care and Monitoring - Competency Skill Sheets

In addition to providing the most concise information for efficiently learning basic human anatomy and physiology, this text also provides guided memorization exercises with complete answer keys for self-testing. The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition of pioneering training systems that then transition into the corporate civilian sector. This manual has been continuously tested and updated to successfully educate every member of the modern United States Army Medical Department (AMEDD). The manuals and course materials combined in this book provide complete, easily understandable, and well-planned learning tools for both military and civilian students. Complete with exercises and answer keys for each lesson. This volume has been used by universities internationally as their foundational instructional textbook. It is essential for any life science field subject to government regulation. It is required material for many regulatory affairs and clinical trial professionals in the pharmaceutical, biotechnology, and medical device industry. Included Documents and Features: Basic Human Anatomy 1. Introduction to Basic Human Anatomy 2. Tissues of the Body 3. The Human Integumentary and Fascial Systems 4. The Human Skeletal System 5. The Human Muscular System 6. The Human Digestive System 7. The Human Respiratory System and Breathing 8. The Human Urogenital Systems 9. The Human Cardiovascular and Lymphatic Systems 10. The Human Endocrine System 11. The Human Nervous System Basic Human Physiology 1. Introduction to Basic Human Physiology 2. Physiology of Cells and Miscellaneous Tissues 3. Envelopes of the Body 4. The Skeletal System 5. Physiology and Actions of Muscles 6. The Human Digestive System 7. The Human Respiratory System and Breathing 8. The Human Urinary System 9. The Human Reproductive (Genital) System 10. Cardiovascular and Other Circulatory Systems of the Human Body 11. The Human Endocrine System 12. The Human Nervous System 13. The Special Senses 14. Some Elementary Human Genetics

This volume is essential for any life science field subject to government regulation. It is required material for many regulatory affairs and clinical trial professionals in the pharmaceutical, biotechnology, and medical device industry. The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition of pioneering training systems that then transition into the corporate civilian sector. This manual has been continuously tested and updated to successfully educate every member of the modern United States Army Medical Department (AMEDD). The manuals and course materials combined in this book provide complete, easily understandable, and well-planned learning tools for both military and civilian students. Complete with exercises and answer keys for each lesson. Included Documents and Features: Pharmacology I 1. Professional References in Pharmacy 2. Anatomy, Physiology, and Pathology Important to Pharmacology 3. Introduction to Pharmacology 4. Local Anesthetic Agents 5. The Central Nervous System 6. Agents Used During Surgery 7. Sedative and Hypnotic Agents 8. Anticonvulsant Agents 9. Psychotherapeutic Agents 10. Central Nervous System (CNS) Stimulants 11. Narcotic Agents ANNEX A. Drug Pronunciation Guide Pharmacology II 1. Dermatological Agents 2. The Human Muscular System 3. Skeletal Muscle Relaxants 4. Analgesic, Anti-Inflammatory, and Antigout Agents 5. Review of Ocular and Auditory Anatomy and Physiology 6. Review of the Autonomic Nervous System 7. Adrenergic Agents 8. Adrenergic Blocking Agents 9. Cholinergic Agents 10. Cholinergic Blocking Agents (Anticholinergic Agents) Pharmacology III 1. The Respiratory System and Respiratory System Drugs 2. The Human Cardiovascular and Lymphatic Systems 3. Cardiac Drugs 4. Vasodilator Drugs 5. Drugs Acting on the Hematopoietic System 6. The Human Urogenital Systems 7. Antihypertensive Agents 8. Diuretic and Antidiuretic Agents 9. Toxicology and Poison Control Pharmacology IV 1. The Human Digestive System 2. Antacids and Digestants 3. Emitics, Antiemetics, and Antidiarrheals 4. Cathartics 5. Fluid and Electrolyte Therapy 6. Review of the Endocrine System 7. Thyroid, Antithyroid, and Parathyroid Preparations 8. Reproductive Hormones and Oral Contraceptives 9. Adrenocortical Hormones 10. Insulin and the Oral Hypoglycemic Agents 11. Oxytocics and Ergot Alkaloids

The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition of pioneering training systems (including computer-based training) that then transition into the corporate sector. This manual has been continuously tested and updated to successfully educate every member of the modern United States Army. The needs of the instructor, the student, and the Army are perfectly balanced. This is the model all educators should follow when developing and delivering training programs. This book is Volume 2 of a 2 volume set and provides an example of how training materials should be designed and delivered for any adult education training program, but especially for any industry that is subject to government regulation. Included Documents and Features: - Overhead Presentation Slides and Student Handouts - Lesson 1: Orientation - Lesson 2: Roles/Responsibilities/Definitions - Group Consensus Exercise (Problem with SGI) - Lesson 3: Group Development - Behavioral Change Chart - Exercise B: Leadership Decision Matrix - Exercise C: Active Listening Exercise - Exercise E: Johari Window Self-Rating Sheet - Lesson 4: Experiential Learning Cycle - The Experiential Learning Model (Blank) - The Experiential Learning Model (Complete) - ELC Questions - Lesson 5: Intervention - Situation 1 - Instructor Qualifications - Situation 2 - War Stories and "Bull Sessions - Situation 3 - Nonparticipation - Situation 4 - Late Student - Situation 5 - The "Angry Huff" - Situation 6 - Les Miserables - Situation 7 - The Filibuster - Situation 8 - The "Corrector" - Situation 9 - "I Agree" - Situation 10 - Critique - Situation 11 - Attack - Situation 12 - Delay - Situation 13 - Self-worth - Situation 14 - Group Norms - Situation 15 - Adam Ant - Lesson 6: Leaderless Discussions - Rules for the Generating Phase of Brainstorming - Rules for Evaluating Phase of Brainstorming - Performance Evaluation Checklist - Performance Evaluation Checklist - Performance Evaluation Checklist - Lesson 7: The Conference - Performance Evaluation Checklist - Lesson 8: Role Playing - The Situation - Observer's Worksheet - Performance Evaluation Checklist - Lesson 9: Committee Problem Solving - Committee Problem Solving-Training Development Exercise - Performance Evaluation Checklist - Lesson 10: Case Studies - Basic Training Instructions: Group Discussion - Basic Training Reading - Performance Evaluation Checklist - Performance Evaluation Checklist - Team Instruction Sheet - Performance Evaluation Checklist

The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition of pioneering training systems (including computer-based training) that then transition into the corporate sector. This manual has been continuously tested and updated to successfully educate every member of the modern United States Army. The needs of the instructor, the student, and the Army are perfectly balanced. This is the model all educators should follow when developing and delivering training programs. This book is Volume 1 of a 2 volume set and provides an example of how training materials should be designed and delivered for any adult education training program, but especially for any industry that is subject to government regulation. Included Documents and Features: 1. Course Management Plan - Overview - Administrative Data - Course Map - Training Facility Requirements - Planning - Instructional Guidance - Student Evaluation Plan - Appendix A: Program of Instruction - Appendix B: Course Management Forms - Appendix C: Course Critique - Appendix D: Student Advance Sheets - Appendix E: Course Schedule - Appendix F: Seating Charts - Appendix G: Course Summary - Appendix H: VTT Suite Equipment 2. Student Handbook - Student Advance Sheet - Student Reference 1. Orientation 2. Experiential Learning Cycle 3. Group Development, Consensus, and Feedback 4. Interventions 5. Johari Window 6. Small Group Instruction: Theory and Practice - Student Guide - Lesson 1: Orientation - Lesson 2: Roles/Responsibilities/Definitions - Lesson 3: Group Development - Lesson 4: Experiential Learning Cycle - Lesson 5: Intervention - Lesson 6: Leaderless Discussions - Lesson 7: The Conference - Lesson 8: Role Playing - Lesson 9: Committee Problem Solving - Lesson 10: Case Studies

The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents. The IOM is recommended reading for all operations regulated by the Food and Drug Administration.

FDA Acronyms, Abbreviations and Terminology provides a quick reference to the acronyms, abbreviations and definitions related to Food and Drug Administration (FDA) human and veterinary products regulatory activities. The emphasis for this reference guide is on scientific, regulatory, government agency, computer application terms, and includes some FDA organizational and program acronyms. Definitions from Title 21 of the United States Code have been included because of their relevance to FDA activities.

This book is designed to be a unified reference source for the U.S. Food and Drug Adminstration's Good Laboratory Practice regulations, guidance, and associated documents for pharmaceutical, biologics and medical device products nonclinical trials. Good Laboratory Practice Regulations and Guidance: * FDA Overview and Orientation * Overview of GCP and Introduction to GLP * Part I: Federal Regulations Relating to Good Laboratory Practice o Parts 58: Good Laboratory Practice for Nonclinical Laboratory Studies o 1987 Final Rule - Good Laboratory Practice Regulations * Part II: Guidance Documents o Bioresearch Monitoring Good Laboratory Practice o Good Laboratory Practices Questions and Answers * Part III: Redbook 2000 o IV.B.1 General Guidelines for Designing and Conducting Toxicity Studies o IV.B.2 Guidelines for Reporting the Results of Toxicity Studies Reference Tools * Part IV: Combined Glossary and Index

This book is designed to be a unified reference source for the U.S. Federal Food, Drug, and Cosmetic Act and is designed to be used both as a reference for experienced industry representatives and as a training resource for those new to the industry. Federal Food, Drug, and Cosmetic Act: * Introduction to the FDA and the FD&C Act * Part I: Federal Food, Drug, and Cosmetic Act o Section Number Reference: Federal Food, Drug, and Cosmetic Act o FD&C Act Chapters I and II: Short Title and Definitions o FD&C Act Chapter III: Prohibited Acts and Penalties o FD&C Act Chapter IV: FoodFD&C Act Chapter V: Drugs and Devices o FD&C Act Chapter VI: Cosmetics o FD&C Act Chapter VII: General Authority o FD&C Act Chapter VIII: Imports and Exports o FD&C Act Chapter IX: MiscellaneousSignificant Amendments to the FD&C Act Reference Tools * Part II: Combined Glossary and Index for all Regulations