Topical Antimicrobials Testing and Evaluation: 2nd Edition (Hardback) book cover

Topical Antimicrobials Testing and Evaluation

2nd Edition

By Daryl S. Paulson

CRC Press

200 pages | 47 B/W Illus.

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Hardback: 9781439813225
pub: 2014-12-20
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Description

A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preoperative skin preparation. Antimicrobial effectiveness, low skin irritation, ease of use, and pleasing aesthetics are all essential if the product is to succeed. In addition, all facets of the product must comply with stringent regulatory requirements. With updated protocols and research, Topical Antimicrobials Testing and Evaluation, Second Edition comprehensively presents and reviews the latest techniques for testing antimicrobial compounds for effectiveness and regulatory compliance.

Topics include:

  • The anatomical structure of the skin and skin microbiology relevant to product testing
  • Use of antimicrobial products against specific microorganisms such as Staphylococcus and Streptococcus species
  • Measurement of antimicrobial action of topical antimicrobials from experimental design, microbiological, biostatistical, and marketplace perspectives
  • Various aspects of the topical antimicrobial products currently in common use in medical, food service, and consumer markets
  • Statistical analysis and specific statistical designs for clinical trials
  • Epistemological requirements in evaluating the effects of specific treatments
  • Evaluation strategies and sample working protocols for hand and body soaps, food-handler antimicrobial products, and medical/healthcare industry antimicrobial products

The book is designed to inform industry and academia on the requirements to get products approved by the FDA and to market while also providing critical insight on ways to best service expanding markets.

Table of Contents

General Approach to Developing Topical Antimicrobials

Business

Quality Assurance

Moving Quality Control Outward

A Tighter Approach to Delivering a Useful Product

The Quadrant Model

A Recurring Problem: Reductionism

Skin Properties

Structure

Epidermis

Dermis

Dermal Vascularization

The Tissue Fluids

Skin Microbiology

Etiology of Infectious Diseases

Bacterial Cell

Mycology (Fungi)

Specific Microorganisms

Staphylococcus

Streptococcus

Other Microorganisms

Fungi

Viruses

Measurement of Antimicrobial Action of Topical Antimicrobials

General Performance Characteristics

Current Topical Antimicrobials

Iodine Complexes

Chlorhexidine Gluconate

Tinctures of CHG and Alcohol

Parachlorometaxylenol

Alcohols Triclosan

Quaternary Ammonium Compounds

General Statistics

Sample Size Determination

What Type of Analysis Should I Use to Ensure the Study

Specific Statistical Designs for Clinical Trials

Preoperative Skin Preparation

Epistemological Requirements in Evaluating the Effects of Specific Treatments

Experimental Strategy

Choice of Qualitative or Quantitative Methods

Statistical Models

Statistical Model-Building and Analysis: Exploratory Phase

Statistical Model Selection

Parametric Statistics

Nonparametric Statistics

Qualitative Research Designs

Phenomenological Designs

Heuristic Designs

Historical Research Design

Evaluative Research Design

Evaluation Strategies and Sample Working Protocols

Consumer Antimicrobial Products

Antimicrobial Efficacy Studies

Sample Protocol: Healthcare Personnel Handwash

Evaluations

General-Use Handwash Evaluation

Medical/Healthcare Industry Antimicrobials

References

Index

About the Author

Daryl S. Paulson, Ph.D., a decorated Vietnam combat veteran, counselor in trauma-associated disorders, and President/CEO of BioScience Laboratories, Inc., has advanced degrees in microbiology, statistics, counseling, human science, and psychology. He has authored numerous articles and 14 books, including Biostatistics and Microbiology: A Survival Manual (Springer, 2009), Applied Statistical Designs for the Researcher (Marcel Dekker, 2003), Handbook of Topical Antimicrobial Testing and Evaluation, Competitive Business, Caring Business: An Integral Perspective for the 21st Century (Paraview Press, 2002), and Haunted by Combat: Understanding PSTD in War Veterans (Greenwood Publishing, 2007).Address correspondence to Daryl S. Paulson, 1765 South 19th Avenue, Bozeman, Montana 59718, or dpaulson@biosciencelabs.com.

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013010
SCIENCE / Chemistry / Analytic
SCI013060
SCIENCE / Chemistry / Industrial & Technical
SCI045000
SCIENCE / Life Sciences / Biology / Microbiology