Handbook of Topical Antimicrobials: Industrial Applications in Consumer Products and Pharmaceuticals (Google eBook)

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CRC Press, Sep 19, 2002 - Science - 464 pages
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This reference examines laboratory techniques and FDA and industry perspectives on medical, food service, and consumer product applications of antimicrobials. It offers methods to conduct investigations of effectiveness that simulate use of consumer, food, and medical antimicrobials in real-world conditions and environments, validate neutralizing systems, develop reliable and functional antimicrobial products, and prevent infection, disease, and contamination. Additional topics include the importance of customer-valued quality attributes, such as low skin irritation and ease of use, label claims, regulatory procedures, and quality control, and clinical simulation protocols.
  

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Contents

Introduction to Topical Antimicrobials and Their Applications
3
Food and Drug Administration Perspective on Topical Antiseptic Drug Product Development
19
Healthcare Continuum A Model for the Classification and Regulation of Topical Antimicrobial Products
49
Topical Antimicrobials
71
Clinical Applications of Povidone Iodine as a Topical Antimicrobial
77
Quaternary Ammonium Compounds
99
Chlorhexidine Gluconate
117
Alcohols
123
Fundamental Steps in Designing a Healthcare Personnel Handwash
241
Food
253
Handwashing Gloving and Disease Transmission by the Food Preparer
255
Handwashing and Gloving for Food Protection Examination of the Evidence
271
Handwashing and Gloving for Food Protection Effectiveness
291
A Suggested Method for Evaluating FoodhandlerProcessor Handwash Formulations
303
Consumer Products
313
Appropriateness of the Healthcare Personnel Handwash Test in Assessing Efficacy of Consumer Handwashing Products
315

Product Applications
131
Microorganisms and Disease
133
Nosocomial Infection
141
Postsurgery Infection
157
Antimicrobial Body Washes
167
Some Aspects of Human Disease and Staphylococcus Species
181
FullBody Shower Wash Efficacy Evaluation of a 4 Chlorhexidine Gluconate
189
Surgical Preparation and Site Access Testings Stepchild
197
Brushless Surgical Scrubbing and Handwashing
221
Development of Methods to Evaluate Efficacy of Handwashing Products for Consumers
333
Importance of Skin Care Attributes in Developing Topical Antimicrobials
355
Testing Methods
363
A Guide for Validation of Neutralizer Systems Used ln Topical Antimicrobial Efficacy Evaluations
365
Testing Methodology of Preoperative Skin Preparation and Surgical Scrub as OvertheCounter Drugs
377
SkinSampling Techniques
395
The Need and Methods for Assessing the Activity of Topical Agents Against Viruses
411
Index
447
Copyright

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Page 7 - FDA's approval of a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) is required before the new drug can be marketed.
Page 23 - An antiseptic-containing preparation designed for frequent use; it reduces the number of transient microorganisms on intact skin to an initial baseline level after adequate washing, rinsing, and drying; it is broad spectrum, fast acting and, if possible, persistent.

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