Sam Salek's Books

Benefit-Risk Assessment of Medicines

The Development and Application of a Universal Framework for Decision-Making and Effective Communication

By: James Leong,Sam Salek,Stuart Walker

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Benefit-Risk Assessment of Medicines

The Development and Application of a Universal Framework for Decision-Making and Effective Communication

By: James Leong,Sam Salek,Stuart Walker

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

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Page Count

326

Publisher

Springer

Published Date

ISBN 10

3319158058

ISBN 13

9783319158051

Benefit-Risk Appraisal of Medicines

A systematic approach to decision-making

By: Filip Mussen,Sam Salek,Stuart Walker

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Benefit-Risk Appraisal of Medicines

A systematic approach to decision-making

By: Filip Mussen,Sam Salek,Stuart Walker

Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines. Benefit-Risk Appraisal of Medicines establishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors’ new model and analyses the implications of its implementation. Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision making Contributes important ideas to the debate on benefit-risk appraisal Provides a future framework for benefit-risk appraisal of medicines Benefit-Risk Appraisal of Medicines covers the entire process from the discovery of new medicines to their marketing and is ideal for all those who work in the pharmaceutical industry and regulatory authorities,, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.

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Page Count

304

Publisher

John Wiley & Sons

Published Date

ISBN 10

0470748125

ISBN 13

9780470748121

Pharmaceutical Regulatory Environment

Challenges and Opportunities in the Gulf Region

By: Reem K. Al-Essa,Mohammed Al-Rubaie,Stuart Walker,Sam Salek

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Pharmaceutical Regulatory Environment

Challenges and Opportunities in the Gulf Region

By: Reem K. Al-Essa,Mohammed Al-Rubaie,Stuart Walker,Sam Salek

This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

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246

Publisher

Springer

Published Date

ISBN 10

3319175904

ISBN 13

9783319175904

Living with Chronic Disease: Measuring Important Patient-Reported Outcomes

By: Paul Kamudoni,Nutjaree Johns,Sam Salek

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Living with Chronic Disease: Measuring Important Patient-Reported Outcomes

By: Paul Kamudoni,Nutjaree Johns,Sam Salek

This book serves as a roadmap for the development and application of patient-reported outcome (PRO) measures, supporting beginners through to experts, as a practical guide. To elucidate on key concepts in the book, examples from clinical research in hyperhidrosis and health-related quality of life and medicines clinical development context, are used. Health-related quality of life represents one of the most commonly measured PROs in both routine clinical practice and research. The book demonstrates the importance of PROs to patients with chronic disease and how such outcomes can assist clinicians in managing patients and monitoring their response to treatment in terms of both symptoms and impacts. This book will benefit readers as a single-source practical guide on the development of modern PRO measures and may also serve as a blueprint for the conceptualization and planning of evidence generation related to PROs in various settings. Ideas and suggestions on how to navigate recent developments shaping the field of PRO measurement are also offered.

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Page Count

170

Publisher

Springer

Published Date

ISBN 10

9811084149

ISBN 13

9789811084140

Pharmaceutical Systems

Global Perspectives

By: John Lilja,Sam Salek,Aldo Alvarez,David Hamilton

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Pharmaceutical Systems

Global Perspectives

By: John Lilja,Sam Salek,Aldo Alvarez,David Hamilton

Offers a social view of the activities leading to the timely patient access to medicines including: drug research, drug production, drug distribution, drug prescribing, drug information and drug control Provides theoretical models to enable pharmacists to understand the organization of drug systems in their particular global territory Written specifically with the needs of pharmacy students taking Master's degrees in mind

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Page Count

356

Publisher

John Wiley & Sons

Published Date

ISBN 10

0470754044

ISBN 13

9780470754047

When Hope Prevails

The Personal Triumph of a Holocaust Survivor

By: Sam Offen

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When Hope Prevails

The Personal Triumph of a Holocaust Survivor

By: Sam Offen

During the Nazi regime, Sam Offen suffered slave labor, ghetto confinement and concentration camp horror. More than 50 members of his immediate and extended family were killed. Despite the pain he has faced, Sam's story of survival is a testimony to triumph of the human spirit. He has shared his experiences with groups at schools, events and the Holocaust Memorial Center in Farmington Hills, Michigan. After much urging by friends and family, he has put his story in writing.

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Page Count

150

Publisher

Nelson Publishing&Marketing

Published Date

ISBN 10

1928623581

ISBN 13

9781928623588

Hemostasis and Thrombosis

Basic Principles and Clinical Practice

By: Victor J. Marder,William C. Aird,Joel S. Bennett,Sam Schulman,Gilbert C. White, II

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Hemostasis and Thrombosis

Basic Principles and Clinical Practice

By: Victor J. Marder,William C. Aird,Joel S. Bennett,Sam Schulman,Gilbert C. White, II

Since publication of the First Edition in 1982, Hemostasis and Thrombosis has established itself as the pre-eminent book in the field of coagulation disorders. No other book is as inclusive in scope, with coverage of the field from the standpoint of both basic scientists and clinicians. This comprehensive resource details the essentials of bleeding and thrombotic disorders and the management of patients with these and related problems, and delivers the most up-to-date information on normal biochemistry and function of platelets or endothelial cells, as well as in-depth discussions of the pharmacology of anticoagulant, fibrinolytic, and hemostatic drugs. NEW to the Sixth Edition... • A new team of editors, each a leader in his field, assures you of fresh, authoritative perspectives. • Full color throughout • A companion website that offers full text online and an image bank. • A new introductory section of chapters on basic sciences as related to the field • Entirely new section on Hemostatic and Thrombotic Disorders Associated with Systemic Conditions includes material on pediatric patients, women's health issues, cancer, sickle cell disease, and other groups. • Overview chapters preceding each section address broad topics of general importance. This is the tablet version which does not include access to the supplemental content mentioned in the text.

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Page Count

5220

Publisher

Lippincott Williams & Wilkins

Published Date

ISBN 10

1451177690

ISBN 13

9781451177695

Living with Chronic Disease: Measuring Important Patient-Reported Outcomes

By: Paul Kamudoni,Nutjaree Johns,Sam Salek

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Living with Chronic Disease: Measuring Important Patient-Reported Outcomes

By: Paul Kamudoni,Nutjaree Johns,Sam Salek

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Page Count

170

Publisher

Springer

Published Date

ISBN 10

9811084149

ISBN 13

9789811084140

Benefit-Risk Assessment of Medicines

The Development and Application of a Universal Framework for Decision-Making and Effective Communication

By: James Leong,Sam Salek,Stuart Walker

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Benefit-Risk Assessment of Medicines

The Development and Application of a Universal Framework for Decision-Making and Effective Communication

By: James Leong,Sam Salek,Stuart Walker

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Solve jigsaw puzzle

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Page Count

326

Publisher

Springer

Published Date

ISBN 10

3319158058

ISBN 13

9783319158051

Pharmaceutical Regulatory Environment

Challenges and Opportunities in the Gulf Region

By: Reem K. Al-Essa,Mohammed Al-Rubaie,Stuart Walker,Sam Salek

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Pharmaceutical Regulatory Environment

Challenges and Opportunities in the Gulf Region

By: Reem K. Al-Essa,Mohammed Al-Rubaie,Stuart Walker,Sam Salek

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Page Count

246

Publisher

Springer

Published Date

ISBN 10

3319175904

ISBN 13

9783319175904

Benefit-Risk Appraisal of Medicines

A systematic approach to decision-making

By: Filip Mussen,Sam Salek,Stuart Walker

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Benefit-Risk Appraisal of Medicines

A systematic approach to decision-making

By: Filip Mussen,Sam Salek,Stuart Walker

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Page Count

304

Publisher

John Wiley & Sons

Published Date

ISBN 10

0470748125

ISBN 13

9780470748121

Real Salt Lake

By: Sam Moussavi

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Real Salt Lake

By: Sam Moussavi

This title introduces soccer fans to the history of one of the top MLS clubs, Real Salt Lake. The title features informative sidebars, exciting photos, a timeline, team facts, a glossary, and an index. Aligned to Common Core Standards and correlated to state standards. SportsZone is an imprint of Abdo Publishing, a division of ABDO.

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ABDO

Published Date

ISBN 10

1098214471

ISBN 13

9781098214470

Book's by Sam Salek

Benefit-Risk Assessment of Medicines

Benefit-Risk Assessment of Medicines

Benefit-Risk Appraisal of Medicines

Benefit-Risk Appraisal of Medicines

Pharmaceutical Regulatory Environment

Pharmaceutical Regulatory Environment

Living with Chronic Disease: Measuring Important Patient-Reported Outcomes

Living with Chronic Disease: Measuring Important Patient-Reported Outcomes

Pharmaceutical Systems

Pharmaceutical Systems

When Hope Prevails

When Hope Prevails

Hemostasis and Thrombosis

Hemostasis and Thrombosis

Living with Chronic Disease: Measuring Important Patient-Reported Outcomes

Living with Chronic Disease: Measuring Important Patient-Reported Outcomes

Benefit-Risk Assessment of Medicines

Benefit-Risk Assessment of Medicines

Pharmaceutical Regulatory Environment

Pharmaceutical Regulatory Environment

Benefit-Risk Appraisal of Medicines

Benefit-Risk Appraisal of Medicines

Real Salt Lake

Real Salt Lake

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