Biologics pr Study guides, Class notes & Summaries

What is Amnion grafts that are rich in growth factors and contain regenerative qualities that maintain the natural healing properties of amnion Key Points of Amnion Protects - acts as an adhesion barrier to help protect tendon and nerves Regeneration- Rich in growth factors that maintain the natural healing properties of amnion Shelf Life of Anmion 5 years, ambient How can you apply amnion in membrane and flowable version for injection What sizes come in Amnion Cord/Thin Cord only c...

Arthrex Amnion Types -AM Thin (100-300 microns) derived frkm amnion membrane layer -AM Cord (800-1000 microns) derived from umblical cord, can hold stitch when hydrated (8x thicker than traditional amnion). -Amnion Viscous (Amniotic Fluid) How is Amnion matrix prepared? Processed via dehydration aseptically in class 100 clean rooms. Amnion Viscous -Store in freezer at -40 deg C (or cooler), can be kept at -20C temporarily for 6 months, after that must be kept at -40 Deg C. -2 year sh...

BCSCP Exam Questions and Answers | 100% Pass!! USP Supplements -Answer-First published in Feb, official Aug 1. Second published in June, official Dec 1. Public Health Service Act -Answer-Biologics License Application (BLA) 351(k) pathway for biosimilars Enforcement of USP Standards -Answer-Responsibility of FDA and other govt authorities. USP has no role in enforcement "About" -Answer-Indicates a quantity within 10% USP 795 bulk product expiration -Answer-Compounder shall label with d...

US RAC-Chapter 22 Questions and Answers Biological Product ANSWER Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically modified synthetic polypeptide), or analogous product... that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Public Health Service (PHS) Act 351(a) ANSWER A biologics license must be in effect for any biological product introduced or d...

NAPSR CNPR Exam Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. - ANS True Average review time for a new drug - ANS 18 months Sales Team - ANS Pg 7 The "engine of innovation," focused on discovering or inventing promising new product. - ANS Research & Development This includes supply chain, manufacturing, trade, and distribution functions of the business. - ANS Man...

CNPR NAPSR Exam Margin of safety - ANS the difference between the usual effective dose and the dose that induces severe or life threatening side effects Rights of drug administration - ANS right patient, right medication, right does, right route of administration, and right time of delivery Injection routes - ANS intramuscular, intrathecal, intravenous, subcutaneous intramuscular - ANS drugs given by direct injection into muscle tissue intrathecal - ANS needle is in...

566 Midterm Study Guide WEEK 1 -Things to know about each of the major antibiotic drug classes • Contraindications and high-risk patients • Know examples of each of the major antibiotic dr ug classes • Monitoring needs • Which ones require renal dosing adjustments and how much (i.e., 25%, 50%, etc.) • Patient education • Lifespan considerations including pregnancy • Indications for use Penicillins • caution with patients allergic reactions to penicillins, cephalosporins, or carba...