The year is 1127 and the Knights Templar in the Holy Land have discovered the riches of King Solomon, King David & Christendom.A single Templar Vessel named the Temple Unicorn is despatched from Dundee in Scotland to the port of Acre in the Holy Land - with an armed guard of fifteen Cistercian Templars to procure the treasures and return many significant pieces to their new Knight custodians across middle Europe and central Asia.The Temple Unicorn embarks on her journey und...

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 need to carry paper books and you can search for key terms.In this issue you will find:Consolidated Guidance: E6: Guidance for Industry - Good Clinical Practice: Consolidated Guidance - ICH April 1996.Guidance for Industry Part 11, Electronic Records; Electronic Signatures —...

Kemp Hastings and his investigative colleague Doctor Darlene Gammay are pursued by the Grand Lodge of Cairo (GLOC) who are hellbent on murdering Darlene now that she has been given a glimpse into the afterlife having been gifted with the power of the ancient Egyptian ritual known as the Assignation.Darlene is transported into the afterlife and endures what she can only describe as a live and very disturbing embalming event, is this an ancient curse that has been bestowed upon the d...

E6 Good Clinical Practice  Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application  CFR 21-- General Part 11, Electronic Records; Electronic Signatures  21 CFR PART 50 Protection Of Human Subjects  21 CFR Part 54 Financial Disclosure By Clinical Investigators  21 CFR PART 56 Institutional Review Boards  Title 21 PART 312 Investigational New Drug Application  ICH E2A Clinica...

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

ICH - Safety Guidelines S1A – S9  S1A Guideline on the Need for Carcinogenicity Studies  S1B Testing for Carcinogenicity of Pharmaceuticals  S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals  S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use  S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxi...

Financial Conflict Of InterestResponsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)Responsible Prospective Contractors (45 C.F.R. Part 94)

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-E4: Dose-Response Information to Support Drug Registration  ICH-E5: Ethnic Factors in the Acceptability of foreign Clinical Data  ICH-E6: Guideline for Good Clinical Practice  ICH-E7: Studies in Support of Specia...

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 Long-term Treatment of Non-Life-Threatening Conditions  ICH-E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting  ICH-E2B(R2) Clinical Safety Data Management : Data Elements for Transmission of...

Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring 

Regulations on: Drug Labeling, Drug Advertising, Drug Marketing, Drug Imprinting, Drug Names, Promotional MaterialsPART 99 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICESPART 200 GENERALPART 201 LABELINGPART 202 PRESCRIPTION DRUG ADVERTISINGPART 203 PRESCRIPTION DRUG MARKETINGPART 206 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USEPART 208 MEDICATION GUIDES FOR PRESCRIPTION DRU...

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 LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS  PART 610 GENERAL BIOLOGICAL PRODUCTS STANDARDS  PART 630 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES  PART 640 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLO...