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Books on the topic 'ICH Guidelines'

Author: Grafiati

Published: 2 June 2025

Last updated: 31 July 2025

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1

Teasdale, Andrew, David Elder, and Raymond W. Nims, eds. ICH Quality Guidelines. John Wiley & Sons, Inc., 2017. http://dx.doi.org/10.1002/9781118971147.

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2

Elias, Mpofu, and Oakland Thomas, eds. Rehabilitation and health assessment: Applying ICF guidelines. Springer, 2009.

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3

Interpharm and International Congress on Harmonization, eds. Validation of analytical procedures: [tripartite ICH guideline (III/5626/94 final)]. Interpharm Press, 1994.

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4

Association, American Hospital, ed. ICD-9-CM official guidelines for coding and reporting. U.S. Dept. of Health and Human Services, 1991.

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5

Tabler, Ronald D. Design guidelines for the control of blowing and drifting snow. Strategic Highway Research Program, National Research Council, 1994.

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6

National Research Council (U.S.). Transportation Research Board. Deicing planning guidelines and practices for stormwater management systems. Transportation Research Board, 2009.

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7

Limited, Martec. Reliability of offshore structural systems: Theory, computation and guidelines for application. National Energy Board, 1993.

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8

United States. Environmental Protection Agency. Office of Science and Technology. Engineering and Analysis Division, ed. Technical development document for proposed effluent limitation guidelines and standards for the airport deicing category. U.S. Environmental Protection Agency, Engineering and Analysis Division, Office of Water / Office of Science and Technology, 2009.

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9

America, Ice Skating Institute of. ISIA hockey game manual: In-house recreational ice hockey guidelines, rules & officials handbook. Ice Skating Institute of America, 1995.

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10

National Cooperative Highway Research Program., American Association of State Highway and Transportation Officials., United States. Federal Highway Administration., and National Research Council (U.S.). Transportation Research Board., eds. Guidelines for the selection of snow and ice control materials to mitigate environmental impacts. Transportation Research Board, 2007.

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11

Organization, World Health, ed. The ICD-10 classification of mental and behavioral disorders: Clinical descriptions and diagnostic guidelines. World Health Organization, 1992.

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12

ICH Harmonised Tripartite Guideline for Good Clinical Practice (ICH Step 4 Guidelines). Brookwood Medical Publications Ltd, 1997.

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13

David, Hutchinson. Indexed ICH GCP Guidelines Pocketbook. Canary Publications, 2002.

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14

Russian Translation of ICH GCP Guidelines for Good Clinical Practice (ICH Step 4 Guidelines). Brookwood Medical Publications Ltd, 2001.

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15

Teasdale, Andrew, David Elder, and Raymond W. Nims. ICH Quality Guidelines: An Implementation Guide. Wiley & Sons, Incorporated, John, 2017.

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16

Teasdale, Andrew, David Elder, and Raymond W. Nims. ICH Quality Guidelines: An Implementation Guide. Wiley & Sons, Limited, John, 2017.

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17

Teasdale, Andrew, David Elder, and Raymond W. Nims. ICH Quality Guidelines: An Implementation Guide. Wiley & Sons, Incorporated, John, 2017.

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18

ICH Quality Guidelines: An Implementation Guide. Wiley, 2017.

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19

ICH Harmonised Tripartite Guideline for Good Clinical Practice, with EC Directive (ICH Step 4 Guidelines). Brookwood Medical Publications, 2001.

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20

DeGeorge, Joseph J., and Jan Willem van der Laan. Global Approach in Safety Testing: ICH Guidelines Explained. Springer London, Limited, 2013.

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21

Global Approach In Safety Testing Ich Guidelines Explained. Springer-Verlag New York Inc., 2013.

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22

Jan Willem van der Laan and Joseph J. DeGeorge. Global Approach in Safety Testing: ICH Guidelines Explained. Springer, 2015.

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23

ICH Harmonised Tripartite Guidelines for Generals Considerations for Clinical Trials. Brookwood Medical Publications Ltd, 1997.

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24

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Setting the scene and ICH GCP in clinical and healthcare research. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0008.

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This chapter looks at the purpose and history of the development of good clinical practice (GCP). The international conference on harmonisation (ICH) GCP is the international quality standard for conducting clinical research to ensure the rights and well-being of patients are protected and the resulting data are valid. The cornerstone of ethics in research stems from the Declaration of Helsinki and the chapter looks at the changes in the Declaration and the impact on clinical trials. The development of the ICH process is described and the E, S, Q and M guidelines are discussed, The efficacy gu

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25

ICH Harmonised Tripartite Guidelines for Data Elements for Transmission of Individual Case Safety. Brookwood Medical Publications Ltd, 1997.

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26

Clinical trials: Study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines. Elsevier/AP, 2012.

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27

Brody, Tom. Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Elsevier Science & Technology Books, 2016.

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28

Brody, Tom. Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Elsevier Science & Technology Books, 2011.

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29

Brody, Tom. Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Elsevier Science & Technology Books, 2016.

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30

The Fundamental Guidelines for Clinical Research: ICH GCP 1996, Declaration of Helsinki 2004, EU Directive 2001/20/EC, EU Directive 2005/28/EC. Institute of Clinical Research, 2005.

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31

Beheiry, Hossam El. Neurophysiology/Neuroprotection. Edited by David E. Traul and Irene P. Osborn. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190850036.003.0027.

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Intracerebral hemorrhage (ICH) is a catastrophic event that may lead to severe disability or death. It is associated with major disruption of intracranial neurophysiology and subsequent neuronal tissue injury. The etiology of ICH may be primary (e.g., hypertensive) or secondary (e.g., traumatic). Treatment options include conservative management or neurosurgical intervention in selected patients. In order to manage these challenging cases, the anesthesiologist and the intensivist should have thorough knowledge pertaining to neurophysiologic concepts of cerebral blood flow, cerebral autoregulat

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32

De laet, Inneke E., and Manu L. N. G. Malbrain. Pathophysiology and management of raised intra-abdominal pressure in the critically ill. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199600830.003.0184.

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The deleterious effects of raised intra-abdominal pressure (IAP) on organ function and mortality have been known for decades, even centuries. Interest in this phenomenon has revived since the 1980s and, recently, the World Society for the Abdominal Compartment Syndrome has published new consensus definitions and guidelines. This chapter will focus on the new definitions for intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS), identify risk factors for the development of IAH/ACS, provide guidelines for IAP monitoring (including when to start, how to measure, and when to

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33

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial protocols: study protocol. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0015.

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This chapter defines protocols and the requirements to be considered when writing a protocol, The protocol is one of the most important documents and must be clear, concise and well written. The chapter describes the procedures before embarking on writing a protocol, who should be involved and describes all the main elements to be included. The ICH E6 guidelines give a complete list of the content of a protocol so this chapter centres on the main decisions/considerations. The main considerations are outlined in a skeleton protocol which includes for example objectives and end points, subject p

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34

Pediatric ICD-10-CM. American Academy of Pediatrics, 2015. http://dx.doi.org/10.1542/9781581109016.

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In this first edition, Pediatric ICD-10-CM: A Manual for Provider-Based Coding strives to bring to the pediatric provider, coder, and biller the most accurate and easy-to use manual on ICD-10-CM yet. Composed entirely with a pediatrics focus, this manual exclusively features codes and guidelines for physician- and provider-based coding, all in a simplified yet familiar format. The full draft of the ICD-10-CM code set comes in at well over 1,000 pages. This book condenses that large and potentially cumbersome book into 400 pages of the most relevant,pediatrics-related codes and guidelines. It a

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35

Optum360º. ICD-10 Essentials: Applying 2021 ICD-10-CM Guidelines. Optum 360, 2020.

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36

ICD-10 Essentials: Applying ICD-10-CM 2020 Guidelines. Optum360º, 2019.

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37

ICD-10 Essentials: Applying ICD-10-PCS Guidelines 2020. Cengage Learning, 2019.

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38

Pediatric ICD-10-CM 2018: A Manual for Provider-Based Coding. American Academy of Pediatrics, 2017. http://dx.doi.org/10.1542/9781610021074.

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For the pediatric provider, coder, and biller, here's the most helpful and easy-to-use manual on ICD-10-CM yet. Featuring a laser-sharp pediatrics focus, it provides codes and guidelines in a simplified, yet familiar format. This purpose-built tool streamlines the coding process by condensing the vast ICD-10-CM code set to only pediatric-centered guidelines and codes. This yields a 50% reduction of codes to search for faster, efficient coding. The guidelines are included directly at the chapter and code level, helping ensure that coders will always use the right codes in the right situations.

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39

Hughes, Cindy, and Becky Dolan, eds. Pediatric ICD-10-CM. American Academy of Pediatrics, 2016. http://dx.doi.org/10.1542/9781610020435.

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For the pediatric provider, coder, and biller, here's the most helpful and easy-to-use manual on ICD-10-CM yet. Featuring a laser-sharp pediatrics focus, this resource provides codes and guidelines in a simplified yet familiar format. Purpose-built to streamline the coding process, this important guide condenses the vast ICD-10-CM code set into a single source for pediatric-centered codes and guidelines. The guidelines are included directly at the chapter and code level, helping ensure that coders will always use the right codes in the right situations. Tabular, indexed navigation helps you fi

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40

ICH Harmonised Tripartite Guideline for Statistical Principles for Clinical Trials. Brookwood Medical Publications Ltd, 1998.

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41

ICC G4-2012 guideline for commissioning. International Code Council, 2012.

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42

Council, International Code. 2003 ICC/ANSI Guidelines: For Accessible & Useable Buildings & Facilities (Icc/Ansi). Cengage Delmar Learning, 2004.

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43

ICD-10-CM Coding Guidelines Made Easy: 2019. Independently published, 2018.

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44

Tropin, Terry. ICD-10-PCS Coding Guidelines Made Easy: 2020. Independently published, 2019.

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45

Tropin, Terry. ICD-10-PCS Coding Guidelines Made Easy: 2019. Independently Published, 2018.

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46

Tropin, Terry. ICD-10-CM Coding Guidelines Made Easy: 2020. Independently Published, 2019.

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47

ICD-10-PCS Coding Guidelines Made Easy: 2021. Independently Published, 2020.

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48

ICD-10-CM Expert for Physicians with Guidelines. Optum360º, 2019.

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49

ICD-10-CM Coding Guidelines Made Easy: 2017. CreateSpace Independent Publishing Platform, 2016.

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50

ICD-10-CM Coding Guidelines Made Easy: 2022. Independently Published, 2021.

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