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 writing ICH E2F Development Safety Update Reports that regulators can tr...

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 a worldwide epidemic of birth defects, and ...

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 problems before a reviewer finds them.Written by Dr. Hafez Selim, MD, PhD, a physicia...

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-central Iran, and all three drew support from arts-loving rulers durin...

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 practical, evidence-based framework for answering those questions. Written by...

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 of self-indulgence. P...

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 never did. EU MDR Article 88 asks for trend reports, ISO 149...

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 whole lifecycle in one volume. It is written by a physician-scientist...

'Drunk or sober, king or soldier, none will be excluded'Sensual, profound, delighted, wise, Hafez's poems have enchanted their readers for more than 600 years. One of the greatest figures of world literature, he remains today the most popular poet in modern Iran.Introducing Little Black Classics: 80 books for Penguin's 80th birthday. Little Black Classics celebrate the huge range and diversity of Penguin Classics, with books from around the world and across many ce...

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 a grid and explains what belongs in each cell.None of them tells you how to reason yo...

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 the grave., Antichrist., ...

An exploration of gender, the Arab Spring, and women's experiences of revolution, including firsthand accounts.In Women of the Midan, Sherine Hafez demonstrates how women were a central part of revolutionary process of the Arab Spring. Women not only protested in the streets of Cairo, they demanded democracy, social justice, and renegotiation of a variety of sociocultural structures. Women's resistance to state control, Islamism, neoliberal market changes, ...