Rapidly becoming one of our most popular titles, this spiral-bound, 5" x 7.5" book is a collection of FDA Guidance documents. It includes those guidances that are most applicable to clinical research staff and includes such topics as:
• Maximum safe starting dose estimates
• Safety assessments prior to drug marketing
• Collecting race/ethnicity data in trials
• Nonclinical evaluation of potential for delayed QT
interval prolongation by human pharmaceuticals
This book is ideal for clinical research staff involved in developing and reviewing protocols, performing safety assessments, and/or writing clinical study reports.
What's the Price?
• 1-249 copies: $18.95 • 250-499 copies: $17.95
• 500-749 copies: $16.95 • 750+ copies: $15.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
• EU Regulation No. 536/2014 on Clinical Trials on Medicinal
Products for Human Use, and Repealing Directive 2001/20/EC
• Draft FDA Guidance: Electronic Source Data in Clinical Investigations
• FDA Policy for Conducting a Clinical Safety Review of an
NDA or BLA (FDA Manual of Policies and Procedures,
MAPP #6010.3, Rev. 1)
• Exception from Informed Consent Requirements for
Emergency Research
• Adverse Event Reporting to IRBs - Improving Human
Subject Protection
• Exploratory IND Studies
• Estimating the Maximum Safe Starting Dose in Initial
Clinical Trials for Therapeutics in Adult Healthy Volunteers
• Collection of Race and Ethnicity Data in Clinical Trials
• Nonclinical Evaluation of the Potential for Delayed
Ventricular Repolarization (QT Interval Prolongation) by
Human Pharmaceuticals (ICH S7B)
• Premarketing Risk Assessment
• Recommended Approaches to Integration of Genetic
Toxicology Study Results
• Fast Track Drug Development Programs - Designation,
Development, and Application Review
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