It takes the average reader 5 hours and 25 minutes to read Benefit-Risk Assessment of Medicines by James Leong
Assuming a reading speed of 250 words per minute. Learn more
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.
Benefit-Risk Assessment of Medicines by James Leong is 317 pages long, and a total of 81,469 words.
This makes it 107% the length of the average book. It also has 100% more words than the average book.
The average oral reading speed is 183 words per minute. This means it takes 7 hours and 25 minutes to read Benefit-Risk Assessment of Medicines aloud.
Benefit-Risk Assessment of Medicines is suitable for students ages 12 and up.
Note that there may be other factors that effect this rating besides length that are not factored in on this page. This may include things like complex language or sensitive topics not suitable for students of certain ages.
When deciding what to show young students always use your best judgement and consult a professional.
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