Skip to main content
Search Button
United States Kobo store Gift Cards Help

Rakuten Kobo

Wishlist

Shopping Cart

You're getting the VIP treatment!

Item(s) unavailable for purchase
Please review your cart. You can remove the unavailable item(s) now or we'll automatically remove it at Checkout.
itemsitem
itemsitem

Recommended For You

Loading...


Showing 1 - 12 of 81 results for “hafez”
Skip side bar filters

  • Mastering the ICSR

    by Hafez Selim ...
    Every adverse event report that reaches a drug safety department becomes an Individual Case Safety Report (ICSR) - and the quality of that case determines whether real safety signals are detected, assessed, and acted on. Mastering the ICSR: Case Processing in Modern Pharmacovigilance is a practical, end-to-end guide to how ICSRs are received, assessed, coded, written, and reported to regulators ... Read more

    $24.99 USD or Free with Kobo Plus

  • Understanding Berberine

    by Hafez Selim ...
    Thinking about berberine for your blood sugar? Read this before you buy a bottle.Berberine is everywhere: social media calls it "nature's Ozempic," and store shelves are full of it. But what can it really do for type 2 diabetes, and is it safe with the medicines you already take?Written by a physician and drug safety expert, Understanding Berberine gives patients and caregivers clear, honest ... Read more

    $6.99 USD or Free with Kobo Plus

  • Writing the DSUR

    by Hafez Selim ...
    Every investigational drug in clinical development produces one document a year that asks a single question: given everything learned this year, is it still reasonable to expose people to this drug in trials? That document is the Development Safety Update Report (DSUR), and the judgment it depends on is usually learned the slow way.Writing the DSUR is a practical, section-by-section manual for ... Read more

    $39.99 USD or Free with Kobo Plus

  • When Medicines Harm

    by Hafez Selim ...
    When Medicines Harm: Fifty-One Case Histories That Shaped PharmacovigilanceMost drug-safety rules were written after something went wrong. This book tells the story behind each one.In 1937 an untested solvent in a new antibiotic syrup killed more than 100 people, and the United States began requiring proof of safety before a drug could be sold. In the early 1960s a sedative sold as harmless caused ... Read more

    $12.99 USD or Free with Kobo Plus

  • Write It Right: A Practical Guide to Medical Device Regulatory Writing

    by Hafez Selim ...
    Clear writing gets devices approved. Vague writing gets deficiency letters.Most regulatory submissions fail because of how the evidence is presented, not because the evidence is missing. Notified body reviewers flag unsupported claims, inconsistent terminology, hedged conclusions, and documents that do not trace back to one another. Write It Right is a practical field guide to fixing those ... Read more

    $19.99 USD or Free with Kobo Plus

  • The Cairo Trilogy

    Palace Walk, Palace of Desire, Sugar Street; Introduction by Sabry Hafez

    by Naguib Mahfouz ...
    Translated by William Maynard Hutchins, Olive E. Kenny, Lorne M. Kenny, Angele Botros Semaan ...
    Series series Everyman's Library Contemporary Classics Series
    Nobel Prize-winner Naguib Mahfouz’s magnificent epic trilogy of colonial Egypt—Palace Walk, Palace of Desire, and Sugar Street—together in one volume.The masterwork of the Nobel Prize-winning author, the three novels of The Cairo Trilogy trace three generations of the family of tyrannical patriarch Al-Sayyid Ahmad Abd al-Jawad, who rules his household with a strict hand while living a secret life ... Read more

    $24.99 USD

  • Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes: A Comprehensive Clinical, Scientific, and Regulatory Guide

    by Dr. Hafez Selim, MD, PhD ...
    Which bone graft is best? That is usually the wrong question.The more useful questions are these: which biological and mechanical properties does this particular defect require, does the proposed graft actually supply them, how strong is the evidence behind that claim, and what safety burden comes with it?Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes offers a ... Read more

    $29.99 USD or Free with Kobo Plus

  • Signal Management in Medical Device Vigilance: From Complaints and Trends to Risk File Updates and Field Safety Action

    by Hafez Selim ...
    The first book on signal management written for medical devices.Device companies receive complaints, code them, decide what is reportable, and file on time. What most of them lack is an owner for the question that connects all of that work: what does this pattern mean, and what must change because of it? Pharmacovigilance answered that question years ago with a named discipline. Device regulation ... Read more

    $29.99 USD or Free with Kobo Plus

  • Faces of Love

    Hafez and the Poets of Shiraz (Penguin Classics Deluxe Edition)

    Translated by Dick Davis ...
    by Hafez, Jahan Malek Khatun, Obayd-e Zakani ...
    Series series Penguin Classics Deluxe Edition
    Acclaimed translator Dick Davis breathes new life into the timeless works of three masters of 14th-century Persian literatureTogether, Hafez, a giant of world literature; Jahan Malek Khatun, an eloquent princess; and Obayd-e Zakani, a dissolute satirist, represent one of the most remarkable literary flowerings of any era. All three lived in the famed city of Shiraz, a provincial capital of south ... Read more

    $13.99 USD

  • Signal Management in Pharmacovigilance: From Detection and Validation to Benefit–Risk Decisions and Regulatory Action

    by Hafez Selim ...
    A practical, end-to-end guide to pharmacovigilance signal management, from the first statistical alert to the final regulatory decision.Most drug safety texts explain how to find a signal. Far fewer show what happens next: how a signal is validated, prioritized, assessed, weighed against benefit, escalated, and closed with a record that holds up. Signal Management in Pharmacovigilance covers that ... Read more

    $29.99 USD or Free with Kobo Plus

  • Practical Benefit–Risk Assessment in Pharmacovigilance From Safety Signals to Regulatory Decisions

    by Hafez Selim ...
    Every periodic safety report ends with the same sentence: the benefit–risk balance remains favourable. Regulatory guidance is excellent at describing what that conclusion must look like on the page. ICH E2C(R2) tells you where the integrated analysis goes. ICH M4E(R2) sets out the subsection structure. GVP Module V defines which risks belong in the safety specification. The FDA framework gives you ... Read more

    $39.00 USD or Free with Kobo Plus

  • God's constitution

    دستور الله

    by Mahmoud Hafez ...
    God’s Constitution descriptions.The meaning of religion.What does religion consist of?The true Meaning of unification.Jurisprudential shariah standardsWhat is the Believe.The Right Act. --> Worship. (Testimony, Prayer. Zakat, Fasting. Hajj) and Transaction. (Inheritance. Economy. Texas. Politics. Social. Feeding. The oath. Hunting. Act....)Knowing of Last day., but not the hour.The punishment of ... Read more

    $3.99 USD or Free with Kobo Plus