Sample Resume Influenza Virus Vaccine - 918 Words

Writing Assignment: 01 Proper Name: Influenza Virus Vaccine Trade name: FLUCELVAX ®1 Product Sponsor: Novartis Vaccines and Diagnostics, Inc.1 Regulatory milestones: 1) BLA submission: November 22, 20111 2) First pre-BLA meeting: July 31, 20071 3) The original BLA submitted in February 2009 was withdrawn to include the results of the clinical endpoint study.1 4) Second pre-BLA meeting: December 15, 20101 5) BLA Approval: November 20, 2012 Pharmacologic Class: Vaccine Introduction and description of the product: FLUCELVAX ® is a first of its kind flu vaccine, approved by U.S. FDA to use cell culture technology. FLUCELVAX ®, an intramuscular injection is used in the prevention of seasonal flu caused by influenza virus types A (subtypes H1N1 and H3N2) and B.1 It is indicated for use in individuals of age 18 years or older.1 The manufacturing process uses mammalian cells instead of chicken eggs to grow viral strains. It is a trivalent and inactivated influenza vaccine, consisting of a continuous cell line of Madin-Darby Canine Kidney (MDCK) cells.1 â€Å"The formulation of FLUCELVAX ® contains 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose in 15 mcg HA of each of the following three influenza strains: A/Brisbane/10/2010 (wild type) (H1N1); A/South Australia/55/2014 (wild type) (H3N2); B/Utah/9/2014. Residual amounts in each dose of FLUCELVAX ® may contain MDCK cell protein (≠¤8.4 mcg), a protein other than HA (≠¤ 120 mcg), MDCK cell DNA (≠¤ 10 ng), polysorbate 80 (≠¤ 1125Show MoreRelatedPsych Exam Chapter 1216262 Words   |  66 Pagestension and headaches. D) an increase in the frequency of cold, influenza, and pneumonia infections. 50. As shown in a bar graph in your textbook, nearly 50 percent of adults across the United States reported _____ after the 9/11 terrorist attacks on the World Trade Center. A) increased use of alcohol, cigarettes, and/or marijuana. B) severe migraine and tension headaches. C) sleep problems and disturbances. D) frequent colds and influenza infections. 51. Walter Cannon is to _____ as Hans Selye isRead MoreDeveloping Management Skills404131 Words   |  1617 PagesDiagnosing the Need for Team Building 531 Comparison Data 531 531 10 LEADING POSITIVE CHANGE 533 SKILL ASSESSMENT 534 Diagnostic Surveys for Leading Positive Change 534 Leading Positive Change 534 Reflected Best-Self Feedbackâ„ ¢ Exercise 535 A Sample E-Mail Request for Feedback 535 Machiavellianism Scale—MACH IV 536 SKILL LEARNING 538 Leading Positive Change 538 Ubiquitous and Escalating Change 539 The Need for Frameworks 539 Tendencies Toward Stability 540 A Framework for Leading Positive Change