Benefit-Risk Appraisal Of Medicines : for every new medicine. the ability...

Benefit-Risk Appraisal of Medicines : the approval process for every new

Benefit-Risk Appraisal of Medicines ability to assess the risks of a new medicine accurately and to...

Author : Filip Mussen, Sam Salek, Stuart Walker

medicine accurately and to balance these against the benefits the medicine could

Publisher : John Wiley & Sons

benefits the medicine could bring is critical for every regulatory authority and

0470748125

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0470748125

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and pharmaceutical company. Despite this there are very few tried and tested

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Benefit-Risk Assessment Of Medicines : documentation system, to facilitate and catalogue benefit-risk...

Benefit-Risk Assessment of Medicines : framework, and accompanying documentation system, to facilitate

Benefit-Risk Assessment of Medicines catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies...

Author : James Leong, Sam Salek, Stuart Walker

benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk

Publisher : Springer

and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing

3319158058

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3319158058

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with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an

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Benefit-Risk Assessment In Pharmaceutical Research And Development : with benefit-risk assessment, despite its growing prominence in...

Benefit-Risk Assessment in Pharmaceutical Research and Development : still largely unfamiliar with benefit-risk assessment, despite its

Benefit-Risk Assessment in Pharmaceutical Research and Development growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap,...

Author : Andreas Sashegyi, James Felli, Rebecca Noel

to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides

Publisher : CRC Press

Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant

143986795X

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considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical

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Quantitative Decisions In Drug Development : drug development. because of the inseparable relationship...

Quantitative Decisions in Drug Development : evidence-based decisions in drug development. because of

Quantitative Decisions in Drug Development inseparable relationship between designs and decisions, a good portion of this book is devoted to the...

Author : Christy Chuang-Stein, Simon Kirby

portion of this book is devoted to the design of clinical trials. The book begins with

Publisher : Springer

design of clinical trials. The book begins with an overview of product development and regulatory approval

3319460765

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product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study

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The Benefit/Risk Ratio : diseases has a long tradition; however,...

The Benefit/Risk Ratio : various types of diseases has a

The Benefit/Risk Ratio however, it has only been recently recognized that the value of any given compound must be...

Author : Hans C. Korting, M. Schafer-Korting

the value of any given compound must be evaluated in light of its benefit to risk

Publisher : CRC Press

evaluated in light of its benefit to risk ratio. When prescribing drugs, physicians must look at

9781439805916

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9781439805916

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drugs, physicians must look at the big picture of the drug's benefits in relation to its

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Decision Making In Health And Medicine : and values / m.g. myriam hunink ... [et...

Decision Making in Health and Medicine : medicine: integrating evidence and values / m.g. myriam

Decision Making in Health and Medicine Hunink ... [et al.]. 2001....

Author : M. G. Myriam Hunink, Milton C. Weinstein, Eve Wittenberg, Joseph S. Pliskin, Michael F. Drummond, Paul P. Glasziou, John B. Wong

Publisher : Cambridge University Press

1107690471

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1107690471

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Strategic Project Risk Appraisal And Management : the right thing' (choosing the...

Strategic Project Risk Appraisal and Management : management skills: 'doing the right

Strategic Project Risk Appraisal and Management right projects) and 'doing things right' (good project management). This book examines the challenges...

Author : Professor Elaine Harris

management). This book examines the challenges that managers face in assessing the likely risks

Publisher : Gower Publishing, Ltd.

face in assessing the likely risks and benefits that need to be taken into

1409458601

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1409458601

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be taken into account when choosing projects. It then explores the strategic level risks

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The Perception And Management Of Drug Safety Risks : consists of twenty-four articles authored by his...

The Perception and management of drug safety risks : of robert gilmer, consists of twenty-four articles

The Perception and management of drug safety risks by his most prominent students and followers. These articles combine surveys of past work by Gilmer...

Author : Bruno Horisberger, Rolf Dinkel, Ciba-Geigy, S.A.

articles combine surveys of past work by Gilmer and others, recent results which have never before

Publisher : Springer

and others, recent results which have never before seen print, open problems, and extensive bibliographies. The

9780387505343

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9780387505343

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problems, and extensive bibliographies. The entire collection provides an in-depth overview of the topics of research

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Improving Drug Safety — A Joint Responsibility : their cost and effectiveness to their...

Improving Drug Safety — A Joint Responsibility : from concern for their cost and

Improving Drug Safety — A Joint Responsibility their real and potential risks and benefits, a critical question has been raised: whose responsibility is it...

Author : Rolf Dinkel, Bruno Horisberger, Kenneth W. Tolo

critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this

Publisher : Springer Science & Business Media

it to improve drug safety? In April 1990, this question became the theme for a conference at

3642612504

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3642612504

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the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international

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Clinical Pharmacology : if drugs are to be used safely and...

Clinical Pharmacology : principles is vital if drugs are to be

Clinical Pharmacology used safely and effectively for increasingly informed patients. Those who clearly...

Author : Morris J. Brown, Pankaj Sharma, Peter N. Bennett

Those who clearly understand how drugs get into the body, how

Publisher : Elsevier Health Sciences

the body, how they produce their effects, what happens to them

0702051136

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0702051136

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in the body, and how evidence of their therapeutic effect is

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Seafood Choices: : and health risks associated with fish and...

Seafood Choices: : the nutritional value and health risks associated

Seafood Choices: fish and shellfish can result in confusion or misperceptions about these food...

Author : Committee on Nutrient Relationships in Seafood: Selections to Balance Benefits and Risks, Food and Nutrition Board, Institute of Medicine

misperceptions about these food sources. Consumers are therefore confronted with a dilemma:

Publisher : National Academies Press

confronted with a dilemma: they are told that seafood is good for

0309102189

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0309102189

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for them and should be consumed in large amounts, while at the

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Occupational Health And Safety In The Care And Use Of Nonhuman Primates : as it pertains to biomedical research. new...

Occupational Health and Safety in the Care and Use of Nonhuman Primates : constantly changes, especially as it pertains to

Occupational Health and Safety in the Care and Use of Nonhuman Primates research. New infectious hazards are of particular importance at nonhuman-primate facilities. For example, the discovery...

Author : National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Committee on Occupational Health and Safety in the Care and Use of Nonhuman Primates

at nonhuman-primate facilities. For example, the discovery that B virus can be transmitted via a

Publisher : National Academies Press

B virus can be transmitted via a splash on a mucous membrane raises new concerns

030908914X

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030908914X

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membrane raises new concerns that must be addressed, as does the discovery of the Reston

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Pharmaceutical Regulatory Environment : performance metrics, including current approval times, review...

Pharmaceutical Regulatory Environment : practices and key performance metrics, including current

Pharmaceutical Regulatory Environment times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for...

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

seven Gulf States. Opportunities for an improved regulatory system are identified, which, if

Publisher : Springer

system are identified, which, if fully implemented, could have a significant impact on

3319175904

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3319175904

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impact on patients’ access to new medicines. The Persian Gulf represents the next

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Training And Professional Support Of Medical Reviewers At The Food And Drug Administration : ...

Training and Professional Support of Medical Reviewers at the Food and Drug Administration :

Training and Professional Support of Medical Reviewers at the Food and Drug Administration ...

Author :

Publisher : National Academies

ISBN

isbn_13


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Prospective Medicine & Health Hazard Appraisal : ...

Prospective medicine & health hazard appraisal :

Prospective medicine & health hazard appraisal ...

Author : Society of Prospective Medicine. Meeting, Sabina Dunton, Lewis A. Miller, University of Arizona. Health Sciences Center, American College of Preventive Medicine

Publisher :

ISBN

isbn_13


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Communicating Risks And Benefits : organization and those people who depend...

Communicating Risks and Benefits : well-being of any organization and those

Communicating Risks and Benefits depend on it. Ineffective communication can cost lives, money and reputations....

Author : Baruch Fischhoff

money and reputations. Communicating Risks and Benefits: An Evidence-Based User’s Guide

Publisher : Government Printing Office

Evidence-Based User’s Guide provides the scientific foundations for effective communications. The

9780160901799

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9780160901799

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book authoritatively summarizes the relevant research, draws out its implications for

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Powerful Medicines : a premium price over your generic...

Powerful Medicines : medication is worth a premium price

Powerful Medicines generic brand, or that doctors have access to all the information they...

Author : Jerry Avorn, M.D.

all the information they need about a drug’s safety and effectiveness each

Publisher : Vintage

safety and effectiveness each time they write a prescription, Dr. Jerry Avorn

0307489752

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0307489752

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Avorn has some sobering news. Drawing on more than twenty-five years of

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WIC Nutrition Risk Criteria : used to establish eligibility for participation in the...

WIC Nutrition Risk Criteria : nutrition risk criteria used to establish eligibility for

WIC Nutrition Risk Criteria participation in the U.S. Department of Agriculture's Special Supplemental Nutrition Program for...

Author : Institute of Medicine, Committee on Scientific Evaluation of WIC Nutrition Risk Criteria

Supplemental Nutrition Program for Women, Infants, and Children (WIC). The volume also

Publisher : National Academies Press

(WIC). The volume also examines the specific segments of the WIC population

9780309175944

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9780309175944

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population at risk for each criterion, identifies gaps in the scientific knowledge

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