C - Drug Guides 1

A comprehensive resource for mental health professionalsーnow in a fully revised and updated tenth edition. The Handbook of Clinical Psychopharmacology for Therapists is the gold standard for mental……続きを見る

It’s in quite alarming and sadden to the basic fact that limitless of human beings is dropping their existence because of micro-organism infections every day without a prolonged lasting answer. Wher……続きを見る

Drugs have played a central role in the progress of human civilization. There are many important stages before a compound is used as a drug to treat a disease. This book deals with the historical as……続きを見る

This issue of Immunology and Allergy Clinics, guest edited by Mariana Castells, is devoted to Drug Hypersensitivity and Desensitizations. Articles in this issue include: Principles and Practice of D……続きを見る

Financial Conflict Of Interest Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) Responsible Prospective Contractors (……続きを見る

Guidance for Industry Oversight of Clinical Investigations ー A Risk-Based Approach to Monitoring 続きを見る

ICH - Safety Guidelines S1A – S9  S1A Guideline on the Need for Carcinogenicity Studies  S1B Testing for Carcinogenicity of Pharmaceuticals  S1C(R2) Dose Selection for Carcinogenic……続きを見る

Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No ne……続きを見る

Good Clinical Practice For Your Reference - Book 5  ICH - Efficacy Guidelines E3 – E15  ICH-E3: Clinical Study Reports ICH-E3 - Structure and Content of Clinical Study Reports  ICH-……続きを見る

Regulations on: Drug Labeling, Drug Advertising, Drug Marketing, Drug Imprinting, Drug Names, Promotional Materials PART 99 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BI……続きを見る

E6 Good Clinical Practice  Guidance for Industry Part 11, Electronic Records; Electronic Signatures ー Scope and Application  CFR 21-- General Part 11, Electronic Records; Electronic Signa……続きを見る

Good Clinical Practice For Your Reference - Book 4  ICH - Clinical Safety E1 - E2F  ICH-E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for……続きを見る

PART 600 BIOLOGICAL PRODUCTS: GENERAL  PART 601 LICENSING  PART 606 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS  PART 607 ESTABLISHMENT REGISTRATION AND PRODUCT……続きを見る

In this ebook you will find the following guidance documents: ICH Q8 Pharmaceutical Development ICH Q9 Quality Risk Management ICH Q10 Pharmaceutical Quality System続きを見る