ABSTRACT

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

chapter 2|4 pages

Assay Development

chapter |16 pages

= E 0/, — = E (y, _ f,,), _

chapter X|19 pages

-c

chapter |7 pages

t statistic:

chapter 3|15 pages

Assay Validation

chapter |13 pages

zip - z - zp + z...)

chapter v|5 pages

)2,

chapter 4|25 pages

Scaleup Design and Analysis

chapter 5|33 pages

USP Tests and Specifications

chapter |4 pages

Y,. over the I

chapter |11 pages

(L,,,U,,), where L — df,

chapter 6|36 pages

Process Validation

chapter 7|12 pages

Quality Assurance

chapter |10 pages

y — e ±

chapter 8|9 pages

Stability Studies

chapter 10|30 pages

Design for Long-Term Stability Studies

chapter 11|10 pages

Stability Analysis with Fixed Batches

chapter 12|17 pages

Stability Analysis with Random Batches

chapter i|25 pages

(01

chapter |3 pages

Appendix A: Statistical Tables

chapter |31 pages

AppendixA . 2