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

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

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

Author : Filip Mussen

medicine accurately and to balance these against the benefits the medicine could bring is critical for

Publisher : John Wiley & Sons

benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this

0470748125

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and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available.

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

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

Benefit-Risk Assessment of Medicines catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the...

Author : James Leong

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

Publisher : Springer

and regulatory agencies have been reviewing the benefit-risk assessment of medicines with

3319158058

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with a view to developing a structured, systematic, standardized approach. Examining the

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

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

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

Author : Andreas Sashegyi

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

Publisher : CRC Press

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

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

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

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

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

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, it...

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

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

Author : Hans C. Korting

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

Publisher : CRC Press

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

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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 side

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Targeted Therapies In Cancer : selectivity because antiproliferative drugs are...

Targeted Therapies in Cancer : encumbered by poor selectivity because

Targeted Therapies in Cancer often toxic not only to tumor cells but also to important populations of the...

Author : Manfred Dietel

also to important populations of the body’s non-neoplastic cells. Modern targeted therapies interact with

Publisher : Springer Science & Business Media

cells. Modern targeted therapies interact with defined molecules present on cancer cells, adding increased

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cells, adding increased selectivity to their toxic effects. This book presents an integrated critical

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

Decision Making in Health and Medicine : medicine: integrating evidence and values /

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

Author : M. G. Myriam Hunink

Publisher : Cambridge University Press

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Safe And Effective Medicines For Children : research equity act (prea) were designed...

Safe and Effective Medicines for Children : and the pediatric research equity act

Safe and Effective Medicines for Children designed to encourage more pediatric studies of drugs used for children. The FDA asked...

Author : Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)

used for children. The FDA asked the IOM to review aspects of pediatric studies

Publisher : National Academies Press

to review aspects of pediatric studies and changes in product labeling that resulted from

0309225507

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that resulted from BPCA and PREA and their predecessor policies, as well as assess

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

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

Improving Drug Safety — A Joint Responsibility their real and potential risks and benefits, a critical question has...

Author : Rolf Dinkel

critical question has been raised: whose responsibility is it to improve

Publisher : Springer Science & Business Media

it to improve drug safety? In April 1990, this question became

3642612504

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the theme for a conference at Wolfsberg, Switzerland, near the shores

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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...

Author : Institute of Medicine

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

Publisher : National Academies Press

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

0309102189

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0309102189

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

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

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

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,...

Author : National Research Council

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

Publisher : National Academies Press

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

030908914X

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030908914X

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

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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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