Friday, January 2, 2009

Quotable Runner or FDA Regulatory Affairs

Quotable Runner: Great Moments of Wisdom, Inspiration, Wrongheadedness, and Humor

Author: Mark Will Weber

Contents
Introduction
The Starting Line
Voices from the Midpack (and Elsewhere)
Coaches
Eat, Drink, But Be Wary
Training
Fear
Racing
Records
Cross-Country
Hills
In the Footsteps of Atalanta
The Marathon
The Mile
Mind Over Matter
The International Runner
Pain
The Olympics
Medals and Money
The Finish Line: Retirement
Victories and Defeats
Who's Who

A few of our favorite quotes:

"Bid me run and I will strive with things impossible." -Shakespeare

"Long distance running is particularly good training in perseverance." -Chairman Mao

"Without ice cream there would be darkness and chaos." -Don Kardong

"Mental will is a muscle that needs exercise, like the muscles of the body." -Lynn Jennings

"If you want to win a race you have to go a little berserk." -Bill Rodgers

"Running is the greatest metaphor for life, because you get out of it what you put into it." -Oprah Winfrey "The mile has all the elements of drama." -Roger Bannister

"Mind is everything. Muscle - pieces of rubber. All that I am, I am because of my mind." -Paavo Nurmi

"The will to win means nothing without the will to prepare." -Juma Ikangaa
"Start slowly, then taper off." -Walt Stack

"Records are made to be broken." -Anonymous

Introduction by Mark Will-Weber

Compiling a book of quotations is a bit like prospecting. For long, unrewarded hours you sift through the silt, murk, and bottom mud which comprise the great body of sports literature and journalism-all for that rare nugget of gold.

I began work on The Quotable Runner withoutactually realizing that I was doing it. (I highly recommend this method for any lengthy task if you can arrange it.) The first few hundred quotations that I gathered were used at the bottom of race results, in batches of five or six quotes per race, which I passed on to the cross-country runners at Moravian College in Bethlehem, Pennsylvania. As their coach, I thought it might be a fun way to jazz up the results sheets and inspire the runners to train with diligence and a new spark. Maybe a line from Zatopek, Nurmi, or Benoit would ignite a dre

Kick!

...[A] hardcover gift book chock full of witty, pithy and inspirational words about the sport....[such as] "If the Lord had meant man to run, he would have given him four legs, or at least made him late for a bus," Red Smith.

Kick!

...[A] hardcover gift book chock full of witty, pithy and inspirational words about the sport....[such as] "If the Lord had meant man to run, he would have given him four legs, or at least made him late for a bus," Red Smith.



Interesting book: Why Youre Wrong About the Right or In the Presence of My Enemies

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

Author: Douglas J Pisano

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

FDA Regulatory Affairs:



Table of Contents:

1 Overview of FDA and drug development Josephine C. Babiarz Babiarz, Josephine C. Douglas J. Pisano Pisano, Douglas J. 1

2 What is an IND? Michael R. Hamrell Hamrell, Michael R. 33

3 The new drug application Charles Monahan Monahan, Charles Josephine C. Babiarz Babiarz, Josephine C. 69

4 Meeting with the FDA Alberto Grignolo Grignolo, Alberto 109

5 FDA medical device regulation Barry Sall Sall, Barry 125

6 The development of orphan drugs Tan T. Nguyen Tan, T. Nguyen 167

7 CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval stages Prabu Nambiar Nambiar, Prabu Steven R. Koepke Koepke, Steven R. 187

8 Overview of the GxPs for the regulatory professional Bob Buckley Buckley, Bob Robert Blanks Blanks, Robert 213

9 FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices Karen L. Drake Drake, Karen L. 267

10 Electronic submissions - a guide for electronic regulatory submissions to FDA Shylendra Kumar Kumar, Shylendra Yolanda Hall Hall, Yolanda Vahe Ghahraman Ghahraman, Vahe 289

11 The practice of regulatory affairs David S. Mantus Mantus, David S. 351

12 A primer of drug/device law : what's the law and how do I find it? Josephine C. Babiarz Babiarz, Josephine C. 369

13 FDA advisory committees Christina A. McCarthy McCarthy, Christina A. David S. Mantus Mantus, David S. 397

14 Biologics Timothy A. Keutzer Keutzer, Timothy A. 417

Index 435

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