The Princess & The Popper

by Judy Gill

Overview

Bonnie’s lonely and Hank The Popper needs help. They team up as “The Princess & The Popper,” amusing friends, tourists, and each other, while earning enough to renovate Hank’s ancestors’ bratwurst wagon. Hank, whose aim is to be a self-made-man, is furious when he learns Bonnie is no pauper. Is he her pet charity? Then when she learns the truth about him, more than corn starts popping!

Product Details

BN ID:	2940011050886
Publisher:	Judy Gill
Publication date:	06/21/2010
Sold by:	Smashwords
Format:	eBook
File size:	320 KB
Age Range:	18 Years

About the Author

Judy Griffith Gill lives on Canada's west coast--the Sunshine Coast of BC--with her husband of (mumblety-five) years. Over those years, they raised two beautiful, successful daughters both of whom are married to fine men and have blessed the Gills with three grandchildren. She is writing less, but enjoying it more, along with summers afloat aboard the cabin cruiser she and her husband own. When not out boating or enjoying dock parties with friends, she grows everything from blueberries to raspberries, interspersed with herbs and plenty of flowers, on her patio. Her oldest daughter, son-in-law, and granddaughter live nearby--near enough her granddaughter willingly waters the plants when Judy is afloat.

Table of Contents

Acknowledgements.

Dedication.

Preface.

Part I. Development of Safety Thresholds, Safety Evaluation, and Qualification of Extractables and Leachable in Orally Inhaled Nasal Drug Products.

1. Chapter 1. Overview of Leachables and Extractables in Orally Inhaled and Nasal Products (Douglas J. Ball, Daniel L. Norwood, Lee M. Nagao).

2. Chapter 2. A General Overview of the Suitability for Intended Use Requirements for Materials Used in Pharmaceutical Systems (Dennis Jenke).

3. Chapter 3. Concepts and Application of Safety Thresholds in Drug Development (David Jacobson-Kram and Ronald D. Snyder).

4. Chapter 4. The Development of Safety Thresholds for Leachables on Orally Inhaled and Nasal Drug Products (W. Mark Vogel).

5. Chapter 5. The Analytical Evaluation Thresholds (AET) and its Relationship to Safety Thresholds (Daniel L. Norwood, James O. Mullis, Scott Pennino).

6. Chapter 6. Safety Thresholds in the Pharmaceutical Development Process for OINDP: An Industry Perspective (David Alexander and James Blanchard).

7. Chapter 7. The Chemistry and Toxicology Partnership: Extractables and Leachables Information Sharing Among the Chemists and Toxicologists (Cheryl L. M. Stults, Ronald Wolff, Douglas J. Ball).

8. Chapter 8. Use of Safety Thresolds in the Pharmaceutical Development Process for OINDP: US Regulatory Perspectives (Timothy J. McGovern).

9. Chapter 9. The Application of Safety Thresholds to Quality Leachables from Plastic Container Closure Systems Intended for Pharmaceutical Products: A Regulatory Perspective (Kumudini Nicholas).

Part 2. Best Practices for Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products.

10. Chapter 10. Analytical Best Practices for the Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products (Dan Norwood, Cheryl Stults and Lee Nagao).

11. Chapter 11. Chemical and Physical Attributes of Plastics and Elastomers: Impact on the Extractables Profile of Container Closure Systems (Michael A Ruberto and Diane Paskiet).

12. Chapter 12. Pharmaceutical Container Closure System – Selection & Qualification of Materials (Douglas J. Ball, William P. Beierschmitt, and Arthur J. Shaw).

13. Chapter 13. Analytical Techniques for Identification of Extractables and Leachables (Dan Norwood, Thomas N. Feinberg, James O. Mullis, and Scott Pennino).

14. Chapter 14. Extractables – The Controlled Extraction Study (Thomas N. Feinberg, Daniel L. Norwood, Alice T. Granger, and Dennis Jenke).

15. Chapter 15. Extractables – Case Study of a Sulfur Elastomer (Daniel L. Norwood, Fenghe Qiu, James Coleman, James O. Mullis, Alice T. Granger, Keith McKellop, Michelle Raikes, John Robson, David Olenski, John Hand, Sr., Melinda K. Munos, Tianjing Deng, Xiaochun Yu, Derek Wood, Shauang Li, Song Klapoetke and Xiaoya Ding).

16. Chapter 16. Extractables – Case Study of a Polypropylene (Diane Paskiet, Laura Stubbs, and Alan D. Hendricker).

17. Chapter 17. Leachables – Analytical Leachables Studies (Andrew D. Feilden and Andy Rignall).

18. Chapter 18. Development and Optimization of Methods for Routine Testing (Cheryl L. Stults and Jason M. Creasey).

19. Chapter 19. Critical Component Quality Control and Specification Strategies (Terrence Tougas, Suzette Roan, and Barbara Falco).

20. Chapter 20. Inorganic Leachables (Diane Paskiet, Ernest L. Lippert, Brian D. Mitchell, and Diego Zurbriggen).

21. Chapter 21. Foreign Particulate Matter (James Coleman, John A. Robson, John A. Smoliga, and Cornelia B. Field).