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Hasil Pencarian

Ditemukan 13 dokumen yang sesuai dengan query
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Cardiovascular clinical trials: putting the evidence into practice
" The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically–relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up. Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. Confidently apply gold standard treatment for 10 of the ... "
Chichester, West Sussex, U.K.: Blackwell , 2013
e20375781
eBooks  Universitas Indonesia Library
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Designs for clinical trials; perspectives on current issues
" This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials ... "
New York: Springer, 2012
e20417633
eBooks  Universitas Indonesia Library
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Selene Baschieri, editor
Innovation in vaccinology: from design, through to delivery and testing
" The aim of this book is to provide an overview of some of the technology platforms that have been realized or are currently under development to try to address unsolved and new issues in the field of vaccine development ... "
Dordrecht: [, Springer], 2012
e20417325
eBooks  Universitas Indonesia Library
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Ton J. Cleophas
Statistics applied to clinical studies
" In the past few years the authors of this 5th edition, as teachers and research supervisors in academic and top-clinical facilities, have been able to closely observe the latest developments in the field of clinical data analysis, and they have been able to assess their performance. The novel methods are explained using practical examples and step-by-step analyses readily accessible for non-mathematicians. All of the novel chapters have been internationally published by the authors in peer-reviewed ... "
Dordrecht: [, Springer], 2012
e20417558
eBooks  Universitas Indonesia Library
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M. Sopiyudin Dahlan
Membaca dan menelaah jurnal uji klinis
Jakarta: Sagung Seto, 2021
617.02 SOP m
Buku Teks  Universitas Indonesia Library
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Brody, Tom
Clinical trials: study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
Amsterdam: Elsevier/Academic Press, 2012
615.507 24 BRO c
Buku Teks  Universitas Indonesia Library
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Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections / Vera Mihajlovic-Madzarevic
" All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug ... "
Hoboken, New Jersey: John Wiley & Sons, 2010
e20376693
eBooks  Universitas Indonesia Library
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Kazmierski, Wieslaw M., editor
Antiviral drugs : from basic discovery through clinical trials
" This book focuses on new small molecule approaches to combat viral infections. The chapters describe the discovery and development from bench through the clinic of relatively recently-approved antiviral drugs and compounds in advanced clinical development. Organized by a virus (such as HIV, HCV, RSV, influenza, HBV and CMV) and written by top academic and industrial authorities in the field, the book provides a unique opportunity to study, understand and apply discovery and development principles and ... "
New Jersey: John Wiley & Sons, 2011
e20375714
eBooks  Universitas Indonesia Library
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Key statistical concepts in clinical trials for pharma / J. Rick Turner
" This book discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual ... "
New York: Springer, 2012
e20401564
eBooks  Universitas Indonesia Library
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Cleophas, Ton J.
Statistical analysis of clinical data on a pocket calculator, part 2 : statistics on a pocket calculator
" The first part of this title contained all statistical tests relevant to starting clinical investigations, and included tests for continuous and binary data, power, sample size, multiple testing, variability, confounding, interaction, and reliability. The current part 2 of this title reviews methods for handling missing data, manipulated data, multiple confounders, predictions beyond observation, uncertainty of diagnostic tests, and the problems of outliers. Also robust tests, non-linear modeling , goodness of fit testing, Bhatacharya models, item ... "
Dordrecht: [Springer, ], 2012
e20419546
eBooks  Universitas Indonesia Library
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