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1

name, No. Vaccine protocols. 2a ed. Totowa, NJ: Humana Press, 2003.

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2

Andrew, Robinson, Cranage Martin P e Hudson Michael, eds. Vaccine protocols. 2a ed. Totowa, N.J: Humana Press, 2003.

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3

L, Hammond Joseph, e Pawlikowski Krzysztof, eds. Telecommunications: Protocols and design. Reading, Mass: Addison-Wesley Pub. Co., 1991.

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4

Sharp, Robin. Principles of protocol design. Berlin: Springer, 2010.

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5

Ehud, Gazit, e Nussinov Ruth, eds. Nanostructure design: Methods and protocols. Totowa, N.J: Humana, 2008.

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6

Lek, Kamol. Cryptography: Protocols, design, and applications. Hauppauge, N.Y: Nova Science Publishers, 2011.

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7

1947-, Robinson Andrew, Farrar Graham H e Wiblin Christopher N, eds. Vaccine protocols. Totowa, N.J: Human Press, 1996.

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8

Kan, Jeff WT, e John S. Gero. Quantitative Methods for Studying Design Protocols. Dordrecht: Springer Netherlands, 2017. http://dx.doi.org/10.1007/978-94-024-0984-0.

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9

Holzmann, Gerard J. Design and validation of computer protocols. London: Prentice-Hall International, 1991.

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10

American Telephone and Telegraph Company., ed. Design and validation of computer protocols. Englewood Cliffs, N.J: Prentice Hall, 1991.

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11

Sharp, Robin. Principles of protocol design. Berlin: Springer, 2008.

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12

Delgrossi, Luca. Design of Reservation Protocols for Multimedia Communication. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4613-1323-6.

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13

Delgrossi, Luca. Design of Reservation Protocols for Multimedia Communication. Boston, MA: Springer US, 1996.

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14

Delgrossi, Luca. Design of reservation protocols for multimedia communication. Boston: Kluwer Academic Publishers, 1996.

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15

1943-, Dhas Chris, Konangi Vijaya K e Sreetharan Muthuthamby, eds. Broadband switching: Architectures, protocols, design, and analysis. Los Alamitos, Calif: IEEE Computer Society Press, 1991.

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16

Enna, S. J. Short protocols in pharmacology and drug discovery: A compendium of mehods from current protocols in Pharmacology. Hoboken: J. Wiley & Sons, 2007.

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17

J, Enna S., e Williams, Michael, 1947 Jan. 3-, eds. Short protocols in pharmacology and drug discovery. Hoboken: J. Wiley & Sons, 2007.

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18

Cramer, Ronald John Fitzgerald. Modular design of secure yet practical cryptographic protocols. S.l: s.n., 1997.

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19

Spohn, Darren L. Data network design. New York: McGraw-Hill, 1993.

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20

Thomas, Thomas M. OSPF network design solutions. 2a ed. Indianapolis, IN: Cisco Press, 2003.

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21

Brenton, Chris. Multiprotocol network design and troubleshooting. San Francisco: Sybex Network Press, 1997.

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22

Konorski, Jerzy. Distributed network protocols for anonymous stations in cooperative and noncooperative settings. Gdańsk: Wydawn. Politechniki Gdańskiej, 2006.

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23

Media, Springer Science+Business, ed. DNA vaccines: Methods and protocols. New York: Humana Press, 2014.

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24

Morris, Stephen Brian. Design and implementation of an SNMPv2 network management system for NetWare and TCP/IP. Dublin: University College Dublin, 1997.

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25

1978-, Shatzkamer Kevin, e Wainner Scott, eds. IP design for mobile networks. Indianapolis, Ind: Cisco Press, 2009.

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26

1978-, Shatzkamer Kevin, e Wainner Scott, eds. IP design for mobile networks. Indianapolis, Ind: Cisco Press, 2009.

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27

Yan, Zhang, e SpringerLink (Online service), eds. RFID Security: Techniques, Protocols and System-on-Chip Design. Boston, MA: Springer-Verlag US, 2009.

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28

American Physiological Society (1887- ). Committee to Develop a Resource Book for Animal Exercise Protocols., ed. Resource book for the design of animal exercise protocols. Bethesda, Md: American Physiological Society, 2006.

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29

Victor, Olifer, ed. Computer networks: Principles, technologies, and protocols for network design. Hoboken, N.J: John Wiley & Sons, 2005.

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30

Bellavance, English Lisa, ed. Combinatorial library methods and protocols. Totowa, N.J: Humana Press, 2002.

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31

Rich, Rosen, ed. Web application architecture: Principles, protocols, and practices. 2a ed. Chichester, West Sussex, England: Wiley, 2009.

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32

Van Zyl, Llewellyn Ellardus, e Sebastiaan Rothmann, eds. Positive Psychological Intervention Design and Protocols for Multi-Cultural Contexts. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-20020-6.

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33

Ghosn, Michel, Bala Sivakumar e Fred Moses. Protocols for Collecting and Using Traffic Data in Bridge Design. Washington, D.C.: National Academies Press, 2011. http://dx.doi.org/10.17226/14521.

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34

Sivakumar, Bala. Protocols for collecting and using traffic data in bridge design. Washington, D.C: Transportation Research Board, 2011.

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35

Mao, Wenbo, Markus Jakobsson e Helger Lipmaa. Cryptographic Protocols, Techniques for Secure Protocol Design. Pearson Education, Limited, 2008.

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36

BGP Design and Implementation. Cisco Press, 2016.

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37

Hudson, Michael, Andrew P. Robinson e Martin P. Cranage. Vaccine Protocols. Humana Press, 2010.

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38

Nanostructure Design: Methods and Protocols. Humana Press, 2008.

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39

Sirna Design Methods And Protocols. Humana Press, 2012.

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40

Taxman, Debra J. Sirna Design: Methods and Protocols. Humana Press, 2016.

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41

Gazit, Ehud, e Ruth Nussinov. Nanostructure Design: Methods and Protocols. Humana Press, 2010.

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42

Churkin, Alexander, e Danny Barash. RNA Design: Methods and Protocols. Springer, 2024.

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43

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher e 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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Resumo:
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 population, study design, study methodology, assessments and timings and statistical considerations. Once these main decisions have been made the first full draft protocol can be written by elaborating every detail and adding the administrative sections as set out in the company/institution SOPs and the ICH GCP guidelines. The process of protocol approval is described along with the requirements for protocol amendments. The additional requirements to be considered in writing protocols for healthcare studies is set out especially the ethical requirements that have to be addressed.
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44

Soloviev, Mikhail. Peptidomics: Methods and Protocols. Humana Press, 2016.

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45

Sharp, Robin. Principles of Protocol Design. Springer, 2008.

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46

Kan, Wai Tak, e John Gero. Quantitative Methods for Studying Design Protocols. Springer Netherlands, 2017.

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47

Kan, Jeff Wt, e John S. Gero. Quantitative Methods for Studying Design Protocols. Springer Netherlands, 2018.

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48

Barz, Hans W., e Gregory A. Bassett. Multimedia Networks: Protocols, Design and Applications. Wiley & Sons, Limited, John, 2016.

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49

Nguyen, Ngoc Quang. Congestion Control: Design, Applications and Protocols. Nova Science Publishers, Incorporated, 2021.

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50

Ewald, L., e S. Westman. Datacommunication: Data Networks, Protocols and Design. Chartwell-Bratt Ltd, 1988.

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