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E-raamat: Drug Information: A Guide for Pharmacists, 7th Edition

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  • Formaat: 912 pages
  • Ilmumisaeg: 19-Nov-2021
  • Kirjastus: McGraw-Hill Education
  • Keel: eng
  • ISBN-13: 9781260460315
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Drug Information: A Guide for Pharmacists, 7th EditionSuurem pilt
  • Formaat: 912 pages
  • Ilmumisaeg: 19-Nov-2021
  • Kirjastus: McGraw-Hill Education
  • Keel: eng
  • ISBN-13: 9781260460315
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Everything pharmacists and pharmacy students need to know about drug information management

A Doody's Core Title for 2022! 

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.



Contributors xxiii
Reviewers xxix
Preface xxxiii
Chapter One Introduction to the Concept of Drug Information
1(32)
J. Russell May
Dianne May
Learning Objectives
1(1)
Key Concepts
1(1)
Introduction
2(2)
The Beginning
4(2)
The Evolution
6(13)
Opportunities in Drug Information Specialty Practice
19(5)
Summary and Direction for the Future
24(1)
Self-Assessment Questions
24(9)
Chapter Two Formulating an Effective Response: A Structured Approach
33(28)
Amy Heck Sheehan
Joseph K. Jordan
Learning Objectives
33(1)
Key Concepts
33(1)
Introduction
34(1)
Steps for Answering a Question
35(2)
Case Study 2-1
37(3)
Case Study 2-2
40(4)
Case Study 2-3
44(3)
Formulating the Response
47(3)
Case Study 2-4
50(4)
Conclusion
54(1)
Self-Assessment Questions
55(6)
Chapter Three Drug Information Resources
61(60)
Meghan K. Lehmann
Anthony Trovato
Learning Objectives
61(1)
Key Concepts
61(1)
Introduction
62(1)
Types of Biomedical Resources
63(2)
Tertiary Resources
65(15)
Case Study 3-1
80(3)
Case Study 3-2
83(6)
Case Study 3-3
89(1)
Secondary Resources
90(7)
Case Study 3-4
97(1)
Primary Resources
97(1)
Case Study 3-5
98(1)
Alternative Resources
99(3)
Case Study 3-6
102(1)
Consumer Health Information
102(3)
Staying Current
105(3)
Reference Budget Considerations
108(1)
Conclusion
109(1)
Self-Assessment Questions
109(12)
Chapter Four Drug Literature Evaluation I: Controlled Clinical Trial Evaluation
121(98)
Jennifer Phillips
Amy Heck Sheehan
Jacob Gettig
Michael G. Kendrach
Learning Objectives
121(1)
Key Concepts
122(1)
Introduction
123(1)
Biomedical/Pharmacy Literature
123(3)
Approach to Evaluating Research Studies (True Experiments)
126(39)
Case Study 4-1
165(13)
Case Study 4-2
178(8)
Specialized Types of Controlled Clinical Trials
186(8)
Case Study 4-3
194(4)
Conclusion
198(1)
Self-Assessment Questions
199(20)
Chapter Five Drug Literature Evaluation II: Beyond the Randomized Controlled Trial
219(78)
Stacy L. Haber
Jason C. Cooper
Christopher S. Wisniewski
Cydney E. McQueen
Learning Objectives
219(1)
Key Concepts
220(1)
Introduction
220(2)
Observational Studies
222(19)
Case Study 5-1 Observational Study
241(1)
Reviews
242(17)
Case Study 5-2 Meta-Analysis
259(1)
Other Study Designs
259(16)
Natural Medicines Medical Literature
275(6)
Case Study 5-3 Study Testing a Natural Medicine
281(1)
Conclusion
282(1)
Self-Assessment Questions
282(15)
Chapter Six The Application of Statistical Analysis in the Biomedical Sciences
297(110)
Ryan W. Walters
Learning Objectives
297(1)
Key Concepts
298(1)
Introduction
298(1)
Populations and Sampling
299(2)
Variables and the Measurement of Data
301(2)
Descriptive Statistics
303(7)
Common Probability Distributions
310(6)
Epidemiological Statistics
316(4)
Types of Study Design
320(2)
Case Study 6-1
322(1)
The Design and Analysis of Clinical Trials
323(7)
Statistical Inference
330(10)
Selecting the Appropriate Statistical Test
340(6)
Case Study 6-2
346(1)
Introduction to Common Statistical Tests
347(50)
Case Study 6-3
397(1)
Conclusion
398(1)
Self-Assessment Questions
399(8)
Chapter Seven Pharmacoeconomics
407(38)
James P. Wilson
Karen L. Rascati
Learning Objectives
407(1)
Key Concepts
407(1)
Introduction
408(1)
Pharmacoeconomics: What Is It and Why Do It?
409(1)
Relationships of Pharmacoeconomics to Outcomes Research
409(1)
Models of Pharmacoeconomic Analysis
409(1)
Assessment of Costs
410(2)
Assessment of Outcomes
412(9)
Performing an Economic Analysis
421(5)
What is Decision Analysis?
426(4)
Steps in Reviewing Published Literature
430(1)
Case Study 7-1
431(5)
Selected Pharmacoeconomic Websites
436(1)
Conclusion
436(1)
Self-Assessment Questions
437(8)
Chapter Eight Evidence-Based Clinical Practice Guidelines
445(42)
Jeanine P. Abrons
Pavnit Kukreja
Learning Objectives
445(1)
Key Concepts
445(1)
Introduction
446(2)
Evidence-Based Medicine and Clinical Practice Guidelines
448(2)
Guideline Development Methods and Evaluation
450(5)
Case Study 8-1
455(4)
Case Study 8-2
459(8)
Case Study 8-3
467(1)
Guideline Evaluation Tools
467(2)
Use of Clinical Practice Guidelines
469(5)
Case Study 8-4
474(1)
Sources of Clinical Practice Guidelines
474(1)
Conclusion
475(1)
Self-Assessment Questions
476(11)
Chapter Nine Journal Clubs
487(14)
Benjamin A. Witt
Brian S. Hoffmaster
Learning Objectives
487(1)
Key Concepts
487(1)
Introduction
488(1)
Conducting Journal Clubs
489(3)
Case Study 9-1
492(1)
Preparing the Presentation
492(2)
Case Study 9-2
494(1)
Case Study 9-3
495(1)
Conclusion
495(1)
Self-Assessment Questions
496(5)
Chapter Ten Peer Review
501(28)
David M. Peterson
Learning Objectives
501(1)
Key Concepts
501(1)
Introduction
502(1)
What Is Peer Review?
503(1)
Criticisms and Variations of Peer Review
504(2)
Reasons to Participate in Peer Review
506(1)
Locating Peer Review Opportunities
507(1)
Preparing for Peer Review
508(1)
Case Study 10-1
509(1)
Reasons to Decline a Peer Review Invitation
509(3)
Case Study 10-2
512(1)
Performing Peer Review
512(2)
Case Study 10-3
514(6)
Involving Learners in Peer Review
520(4)
Conclusion
524(1)
Self-Assessment Questions
524(5)
Chapter Eleven Legal Aspects of Drug Information
529(72)
Martha M. Rumore
Learning Objectives
529(1)
Key Concepts
529(1)
Introduction
530(1)
Tort Law
531(1)
Case Study 11-1
532(2)
Case Study 11-2
534(10)
Defenses to Negligence and Malpractice Protection
544(5)
Labeling and Advertising
549(1)
Direct-to-Consumer (DTC) Drug Information
550(3)
Off-Label Use and Informed Consent
553(6)
Liability Concerns for Internet/Social Media Information
559(5)
Fraud and Abuse
564(2)
Intellectual Property Rights
566(3)
Case Study 11-3
569(5)
Privacy
574(3)
Case Study 11-4
577(3)
Industry Support for Educational Activities
580(4)
Conclusion
584(1)
Self-Assessment Questions
585(16)
Chapter Twelve Ethical Aspects of Drug Information Practice
601(38)
Elyse A. MacDonald
Learning Objectives
601(1)
Key Concepts
601(1)
Introduction
602(4)
Basics of Ethics Analysis
606(8)
Case Example 12-1 (Micro-Level Case)
614(5)
Case Example 12-2 (Meso-Level Case)
619(3)
Case Study 12-1 (Micro Level)
622(1)
Case Study 12-2 (Micro Level)
623(1)
Case Study 12-3 (Meso Level)
624(1)
Case Study 12-4 (Macro Level)
625(1)
Resources for Use by Professionals Seeking to Learn More about Medical Ethics, as Applied to Issues Involving Provision of Drug Information
626(2)
Structures That Support Ethical Decision-Making
628(3)
Conclusion
631(1)
Self-Assessment Questions
631(8)
Chapter Thirteen Professional Communication of Drug Information
639(50)
Patrick M. Malone
Meghan J. Malone
Learning Objectives
639(1)
Key Concepts
640(1)
Introduction
640(1)
Steps in Writing
641(19)
Case Study 13-1
660(1)
Specific Documents
660(8)
Case Study 13-2
668(9)
Case Study 13-3
677(1)
Conclusion
677(1)
Self-Assessment Questions
677(12)
Chapter Fourteen Media Relations
689(10)
Erin R. Fox
Linda S. Tyler
Learning Objectives
689(1)
Key Concepts
689(1)
Introduction
689(1)
Working with the Media
690(1)
Case Study 14-1
690(1)
Case Study 14-2
691(3)
Case Study 14-3
694(1)
Summary
695(1)
Self-Assessment Questions
695(4)
Chapter Fifteen Pharmacy and Therapeutics Committee
699(76)
Patrick M. Malone
Mark A. Malesker
Indrani Kar
Danial E. Baker
Sunil Kumar Jagadesh
Learning Objectives
699(1)
Key Concepts
699(1)
Introduction
700(1)
Case Study 15-1
701(1)
Organizational Background
702(8)
Pharmacy Support of the P&T Committee
710(11)
P&T Committee Meeting
721(1)
P&T Committee Functions
722(17)
Case Study 15-2
739(12)
Case Study 15-3
751(1)
Communication within an Organization
752(2)
Case Study 15-4
754(1)
Conclusion
755(1)
Study Questions
755(1)
Self-Assessment Questions
756(3)
Acknowledgment
759(16)
Chapter Sixteen Drug Evaluation Monographs
775(46)
Patrick M. Malone
Mark A. Malesker
Indrani Kar
Danial E. Baker
Sunil Kumar Jagadesh
Learning Objectives
775(1)
Key Concepts
775(1)
Introduction
776(1)
Purpose of Drug Evaluation Monographs
777(1)
Sources of Drug Monographs
778(1)
Contents of the Drug Monograph
779(2)
Importance of the Drug Monograph
781(1)
Summary Page
782(12)
Body of the Monograph
794(14)
Distribution of Drug Formulary
808(1)
Conclusion
808(1)
Case Study 16-1
809(1)
Case Study 16-2
809(1)
Case Study 16-3
809(1)
Case Study 16-4
810(1)
Case Study 16-5
811(1)
Case Study 16-6
811(1)
Self-Assessment Questions
811(2)
Acknowledgment
813(8)
Chapter Seventeen Drug Shortages and Counterfeit Drugs
821(14)
Erin R. Fox
Learning Objectives
821(1)
Key Concepts
821(1)
Introduction
822(1)
Drug Shortages
822(2)
Case Study 17-1
824(3)
Case Study 17-2
827(1)
Case Study 17-3
828(1)
Counterfeit Drugs
829(1)
Conclusion
830(1)
Self-Assessment Questions
830(5)
Chapter Eighteen Quality Improvement and the Medication Use System
835(60)
Jennifer K. Thomas
Rachel Digmann
Learning Objectives
835(1)
Key Concepts
835(1)
Introduction
836(1)
The Changing Environment for Health Care Quality
837(1)
Case Study 18-1
838(2)
Case Study 18-2
840(1)
Purpose of Measuring Quality
841(1)
Quality Measures
841(2)
Quality Improvement
843(18)
Case Study 18-3
861(1)
Case Study 18-4
862(8)
Case Study 18-5
870(2)
Case Study 18-6
872(7)
Quality in Drug Information
879(1)
Publication of Quality Improvement Studies
880(1)
Conclusion
881(1)
Self-Assessment Questions
881(14)
Chapter Nineteen Medication Safety I: Adverse Drug Reactions
895(38)
Kelly Besco
Megan E. Keller
Learning Objectives
895(1)
Key Concepts
895(1)
Introduction
896(1)
Impact of Adverse Drug Reactions
897(1)
Definitions
898(1)
Causality and Probability of Adverse Drug Reactions
899(5)
Case Study 19-1
904(1)
Classification of Adverse Drug Reactions
905(3)
Implementing a Program
908(2)
The Role of Technology in ADR Surveillance
910(2)
Reporting Adverse Drug Reactions
912(7)
Case Study 19-2
919(1)
Case Study 19-3
920(1)
Future Approaches to Pharmacovigilance
921(1)
Conclusion
922(1)
Self-Assessment Questions
923(10)
Chapter Twenty Medication Safety II: Medication Errors
933(46)
Katie Johnson
Liz Hess
Learning Objectives
933(1)
Key Concepts
933(1)
Introduction
934(1)
Definitions: Medication Errors, Adverse Drug Events (ADES), and Adverse Drug Reactions (ADRS)
935(2)
The Impact of Errors on Patients and Health Care Systems
937(1)
Identification and Reporting of Medication Errors and Adverse Drug Events
938(4)
Classification of Error Types
942(3)
Classifying Patient Outcomes
945(1)
External Reporting
946(1)
Managing an Event Reporting System
947(3)
Human Error or System Error?
950(4)
Case Study 20-1
954(1)
Risk Factors for Errors and Events
955(3)
Types of Safety Analyses
958(2)
Case Study 20-2
960(1)
Just Culture
961(3)
Case Study 20-3
964(1)
Key Organizations for Safety Best Practices
965(2)
Case Study 20-4
967(1)
Conclusion: Safety as a Priority
968(1)
Self-Assessment Questions
969(10)
Chapter Twenty-One Policy, Procedure, and Guideline Development
979(16)
Whitney Mortensen
Gregory Heindel
Conor Hanrahan
Learning Objectives
979(1)
Key Concepts
979(1)
Introduction
980(1)
Regulatory Considerations
981(1)
Practice Document Design and Organization
981(1)
Factors Influencing Practice Document Development
982(2)
Systematic Method for Practice Document Development and Maintenance
984(2)
Case Study 21-1
986(3)
Conclusion
989(1)
Case Study 21-2
989(1)
Self-Assessment Questions
990(5)
Chapter Twenty-Two Project Management
995(18)
Conor Hanrahan
Candice Burns Wood
Learning Objectives
995(1)
Key Concepts
995(1)
Introduction
996(1)
Projects, Programs, and Portfolios
997(1)
Selecting Projects
998(1)
Initiating a Project
999(3)
Planning a Project
1002(3)
Case Study 22-1
1005(2)
Executing a Project
1007(1)
Monitoring and Controlling a Project
1007(1)
Closing a Project
1008(1)
Conclusion
1008(1)
Self-Assessment Questions
1009(4)
Chapter Twenty-Three Investigational Drugs
1013(46)
Bambi J. Grilley
Learning Objectives
1013(1)
Key Concepts
1014(1)
Introduction
1015(1)
History of Drug Development Regulation in the United States
1015(5)
The Drug Approval Process
1020(8)
Case Study 23-1
1028(6)
Case Study 23-2
1034(1)
The Orphan Drug Act
1035(1)
Institutional Review Board/Institutional Ethics Committee
1036(2)
Case Study 23-3
1038(1)
Role of the Health Care Professional
1038(9)
Conclusion
1047(1)
Self-Assessment Questions
1047(12)
Chapter Twenty-Four Regulatory Affairs and Pharmaceutical Industry
1059(48)
Jennifer L. Dill
Daniel A. Kapp
Learning Objectives
1059(1)
Key Concepts
1059(1)
Introduction
1060(1)
Anatomy of the Department of Health and Human Services and the Food and Drug Administration
1061(10)
Division of Drug Information
1071(5)
Case Study 24-1
1076(1)
Opportunities within the FDA
1077(2)
The Food and Drug Administration and the Pharmaceutical Industry
1079(1)
Medical Communications in the Pharmaceutical Industry
1080(1)
FDA Regulatory Oversight
1080(3)
Fulfillment of Medical Information Requests
1083(2)
Case Study 24-2
1085(1)
Required Safety Reporting to FDA
1085(2)
Case Study 24-3
1087(1)
Code on Interactions with Healthcare Professionals
1088(1)
Opportunities for Health Professionals within Industry
1088(7)
Conclusion
1095(1)
Self-Assessment Questions
1095(12)
Chapter Twenty-Five Assessing Drug Promotions
1107(56)
Genevieve Lynn Ness
Robert D. Beckett
Learning Objectives
1107(1)
Key Concepts
1108(1)
Introduction
1108(1)
Ethical Criteria for Medicinal Drug Promotion
1109(1)
Direct-to-Consumer Advertising (DTCA)
1110(18)
Case Study 25-1
1128(1)
Promotions to Health Care Professionals
1129(7)
Case Study 25-2
1136(1)
Case Study 25-3
1137(3)
Case Study 25-4
1140(3)
Conclusion
1143(1)
Self-Assessment Questions
1143(20)
Chapter Twenty-Six Drug Information in Ambulatory Care
1163(30)
Suzanne M. Surowiec
Learning Objectives
1163(1)
Key Concepts
1163(1)
Introduction
1164(1)
Providing Drug Information in the Ambulatory Care Setting
1165(3)
Drug Information Responsibilities in Ambulatory Care
1168(5)
Case Study 26-1
1173(6)
Case Study 26-2
1179(3)
Case Study 26-3
1182(4)
Case Study 26-4
1186(1)
Conclusion
1187(1)
Self-Assessment Questions
1187(6)
Chapter Twenty-Seven Drug Information and Contemporary Community Pharmacy Practice
1193(34)
Morgan L. Sperry
Heather A. Pace
Learning Objectives
1193(1)
Key Concepts
1193(1)
Introduction
1194(2)
Pharmacists as Drug Information Providers
1196(2)
Patient Sources of Drug Information
1198(5)
Case Study 27-1
1203(7)
Case Study 27-2
1210(1)
Case Study 27-3
1210(1)
A New Model of Drug Information
1210(5)
Conclusion
1215(1)
Self-Assessment Questions
1216(11)
Chapter Twenty-Eight Pharmacy Informatics I: Systems and Technology for Patient Care
1227(40)
Brent I. Fox
Joshua C. Hollingsworth
Learning Objectives
1227(1)
Key Concepts
1228(1)
Introduction
1228(1)
Medication-Use Proces
1229(3)
Pharmacy Informatics
1232(1)
Order Entry (Prescribing Stage)
1233(6)
Case Study 28-1
1239(1)
Order Verification
1240(1)
Dispensing
1241(3)
Administration
1244(1)
Monitoring
1245(2)
Case Study 28-2
1247(1)
Case Study 28-3
1248(1)
The Future: Informatics in the U.S. Health Care System
1248(3)
Case Study 28-4
1251(3)
Case Study 28-5
1254(3)
Conclusion
1257(1)
Self-Assessment Questions
1257(10)
Chapter Twenty-Nine Pharmacy Informatics II: Big Data
1267(28)
Marc A. Willner
Eric D. Vogan
Learning Objectives
1267(1)
Key Concepts
1267(1)
Introduction
1268(1)
Reporting and Analytics
1268(6)
Case Study 29-1
1274(1)
Big Data
1275(4)
Case Study 29-2
1279(1)
Artificial Intelligence
1280(6)
Conclusion
1286(1)
Self-Assessment Questions
1287(8)
Chapter Thirty Drug Information Education and Training
1295(20)
Michelle W. McCarthy
Learning Objectives
1295(1)
Key Concepts
1295(1)
Introduction
1296(1)
Drug Information in Pharmacy Curriculum
1296(2)
Case Study 30-1
1298(4)
Case Study 30-2
1302(1)
Postgraduate Training in Drug Information
1302(3)
Case Study 30-3
1305(1)
Pursuing Specialty Training
1306(1)
Conclusion
1307(1)
Self-Assessment Questions
1307(8)
Appendices
1315(136)
Appendix 2-1 Example of Drug Information Consult Documentation Form
1317(2)
Appendix 2-2 Standard Questions for Obtaining Background Information from Requestors
1319(5)
Appendix 3-1 Performing a PubMed Search
1324(3)
Appendix 3-2 Selected Primary Literatures Sources
1327(4)
Appendix 4-1 Drug Literature Assessment Questions for Clinical Trials
1331(3)
Appendix 5-1 Drug Literature Assessment Questions for Other Study Designs
1334(5)
Appendix 8-1 Grade Evidence Profile: Antibiotics for Children with Acute Otitis Media
1339(2)
Appendix 12-1 Code of Ethics for Pharmacists
1341(2)
Appendix 13-1 Question Example
1343(2)
Appendix 13-2 Abstracts
1345(8)
Appendix 13-3 Bibliography
1353(15)
Appendix 15-1 Pharmacy and Therapeutics Committee Procedure
1368(13)
Appendix 15-2 Formulary Request Form
1381(3)
Appendix 15-3 P&T Committee Meeting Attributes
1384(2)
Appendix 15-4 Example P&T Committee Minutes
1386(2)
Appendix 15-5 Chairperson Skills
1388(2)
Appendix 15-6 Conflict of Interest Declaration
1390(2)
Appendix 16-1 Format for Drug Monograph
1392(4)
Appendix 16-2 Example Drug Monograph
1396(7)
Appendix 16-3 Biosimilar Monograph
1403(3)
Appendix 18-1 Tools Used in Quality Assurance
1406(5)
Appendix 18-2 Example of Criteria and Request for Approval
1411(1)
Appendix 18-3 Example of Medication Use Evaluation (MUE) Results
1412(3)
Appendix 18-4 Evaluation Form for Drug Information Response
1415(1)
Appendix 19-1 Kramer Questionnaire
1416(7)
Appendix 19-2 Naranjo Algorithm
1423(1)
Appendix 19-3 Jones Algorithm
1424(1)
Appendix 19-4 Liverpool ADR Causality Assessment Tool
1425(1)
Appendix 19-5 MedWatch Form
1426(3)
Appendix 21-1 Policy Example: High-Alert Medications
1429(5)
Appendix 22-1 Example of a Project Charter
1434(4)
Appendix 22-2 Stakeholder Matrix---IV Compounding Software Project
1438(2)
Appendix 22-3 Example PESTLE Analysis---IV Compounding Software Project
1440(3)
Appendix 22-4 Example Work Breakdown Structure (WBS)---IV Compounding Software Project
1443(3)
Appendix 24-1 Example REMS Template for Writing Participant Information
1446(3)
Appendix 24-2 Response Letter Drug A---Incidence of Yellow Stripes
1449(2)
Glossary 1451(42)
Case Study Answers 1493(40)
Abbreviations 1533(10)
Answers for Self-Assessment Questions 1543(8)
Index 1551
Patrick Malone, PharmD Director, Web-Based Pharmacy Pathway Creighton University School of Pharmacy Omaha, NE
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