Michael J Klepper (17 results)

Condition: good. Books may contain some notes and highlighting. Supplements such as Access Codes, Cd's Dust Jackets, etc. are not guaranteed with used book purchases.

Paperback. Condition: Good. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices.Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting.Key features include:* Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports* Pragmatic tips?and mistakes to avoid* Simple explanations of what safety data are collected, and what the data mean* Practical approaches to determining a drug effect and understanding its clinical significance* Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical* Examples of user-friendly data displays that enhance safety signal identification* Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting* Relevant material for the required training of drug safety/pharmacovigilance professionals* SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR). …

Paperback. Condition: Good. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices.Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting.Key features include:* Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports* Pragmatic tips?and mistakes to avoid* Simple explanations of what safety data are collected, and what the data mean* Practical approaches to determining a drug effect and understanding its clinical significance* Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical* Examples of user-friendly data displays that enhance safety signal identification* Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting* Relevant material for the required training of drug safety/pharmacovigilance professionals* SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR). …

Paperback. Condition: Very Good. Very Good - . In very good condition.

Condition: As New. Unread book in perfect condition.

Condition: As New. Unread book in perfect condition.

Condition: New.

PAP. Condition: New. New Book. Shipped from UK. Established seller since 2000.

Kartoniert / Broschiert. Condition: New. KlappentextThis must-have guide is geared toward providing a clinical framework for analyses, interpretation and summarization of safety data for those individuals with or without medical training/clinical experience identifying common .

Condition: New.

Condition: New. Num Pages: 316 pages, black & white illustrations, black & white tables, figures. BIC Classification: GBC; MR. Category: (G) General (US: Trade). Dimension: 275 x 217 x 18. Weight in Grams: 758. . 2010. 1st Edition. Paperback. . . . .

Taschenbuch. Condition: Neu. Neuware - This must-have guide is geared toward providing a clinical framework for analyses, interpretation and summarization of safety data for those individuals with or without medical training/clinical experience; identifying common pitfalls and providing pragmatic solutions; and providing clear examples of proven approaches for handling specific analyses, data displays, and data interpretation.…

Condition: New. pp. xix + 312.

Condition: New. pp. xix + 312 Illus.

Condition: New. Num Pages: 316 pages, black & white illustrations, black & white tables, figures. BIC Classification: GBC; MR. Category: (G) General (US: Trade). Dimension: 275 x 217 x 18. Weight in Grams: 758. . 2010. 1st Edition. Paperback. . . . . Books ship from the US and Ireland.

Condition: New. In English.

Tankobon Hardcover. Condition: Brand New. Japanese language. 11.65x8.27x1.02 inches. In Stock.