DRUG SAFETY
EVALUATION
DRUG SAFETY
EVALUATION

SHAYNE C. GAD

A John Wiley & Sons, Inc., Publication
This book is printed on acid-free paper.
Copyright # 2002 by John Wiley and Sons, Inc., New York. All rights reserved.
Pub...
To Spunky Dustmop, who always listens
so well and is always there.
CONTENTS

Preface

ix

About the Author

xi

Chapter 1

Strategy and Phasing for Drug Safety Evaluation in the
Discovery a...
viii

CONTENTS

Chapter 12

Special Concerns for the Preclinical Evaluation of
Biotechnology Products

404

Chapter 13

Fo...
PREFACE

Drug Safety Evaluation has been written with the central objective of presenting an
all-inclusive practical guide...
ABOUT THE AUTHOR

Shayne C. Gad, Ph.D. (Texas, 1977), DABT, ATS, has been the Principal of Gad
Consulting Services since 1...
Drug Safety Evaluation. Shayne C. Gad
Copyright  2002 John Wiley & Sons, Inc.
ISBN: 0-471-40727-5

1
STRATEGY AND PHASING...
2

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

eventual use of a drug are based on an understanding of both the poten...
1.1. INTRODUCTION

3

FIGURE 1.1. Attrition during the development of new molecules with a promise of
therapeutic potentia...
4

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

support of successive decision points (go=no-go points) in the develop...
5

Liver=Kidney Damage
QT internal prolongation=
ventricular arrhythmias (deaths)
Drug-drug interactions
Bowel Obstruction...
6

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

adverse drug events and deaths in hospital patients. It is hoped that ...
1.2. REGULATORY REQUIREMENTS

7

Guidelines establish which studies must be done for each step in the process of
developme...
8
I, II
III
NDA
I, II
III

Several days (up to 3)
Up to 2 weeks

Up to 3 months

6 months to unlimited

Oral or parenteral...
9

Single application
Multiple application

III
NDA

Short-term application
Unlimited application

Vaginal or rectal

II

...
10

Duration of human
administrationa

Drug combinationsd
2 species: up to
3 months

Phaseb
Subacute or chronic
toxicityc
...
1.3. ESSENTIAL ELEMENTS OF PROJECT MANAGEMENT

11

The individual studies and reports are to be tied together to present a...
12

FIGURE 1.2. An example PERT (Program Evaluation Review Technique) chart of the development of a new pharmaceutical thr...
1.3. ESSENTIAL ELEMENTS OF PROJECT MANAGEMENT

13

TABLE 1.3. Glossary of Project Management Terms
Activity
Average daily
...
14

FIGURE 1.3. A GANTT or bar chart showing scheduling of the major safety assessment activities (studies) involved in a ...
1.4. SCREENS: THEIR USE AND INTERPRETATION IN SAFETY ASSESSMENT

15

FIGURE 1.4. A hybrid project GANTT chart, which ident...
16

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

Each test or assay has an associated activity criterion, that is, a l...
1.4. SCREENS: THEIR USE AND INTERPRETATION IN SAFETY ASSESSMENT

17

activities in a compound can be estimated from past e...
18

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

6. In an effort to better serve item (2), safety assessment screens a...
1.5. STRATEGY AND PHASING

19

the pieces are coordinated well and utilized effectively (and completed at the right
times)...
20

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

FIGURE 1.5. Three different approaches to matching preclinical safety...
1.5. STRATEGY AND PHASING

3.
4.
5.
6.

21

Identify very or unusually toxic agents.
Estimate lethality potential.
Evaluat...
22

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

For all the literature on project management, however, a review will ...
1.5. STRATEGY AND PHASING

23

If, instead of contracting out, one is concerned with managing a testing
laboratory, then t...
24

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

this peak load and since the skills of these two groups are somewhat ...
1.6. CRITICAL CONSIDERATIONS

25

Safety evaluation does not cease being an essential element in the success of the
pharma...
26

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

L ¼ a loss or efficiency factor (to allow for losses in formulation an...
REFERENCES

27

Drugs intended to treat a life-threatening disease for which there is no effective
treatment are generally...
28

STRATEGY AND PHASING FOR DRUG SAFETY EVALUATION

Beyer, K. (1978). Discovery, Development and Delivery of New Drugs. M...
REFERENCES

29

O’Grady, J. and Linet, O.I. (1990). Early Phase Drug Evaluation in Man. CRC Press, Boca
Raton, FL.
Raeburn...
Drug Safety Evaluation. Shayne C. Gad
Copyright  2002 John Wiley  Sons, Inc.
ISBN: 0-471-40727-5

2
REGULATION OF HUMAN
P...
2.2. BRIEF HISTORY OF U.S. PHARMACEUTICAL LAW

31

2.2. BRIEF HISTORY OF U.S. PHARMACEUTICAL LAW
A synopsis of the history...
32

REGULATION OF HUMAN PHARMACEUTICAL SAFETY

TABLE 2.1. Important Dates in U.S. Federal Drug Lawa
Year

Event

1902

Pas...
2.2. BRIEF HISTORY OF U.S. PHARMACEUTICAL LAW

33

TABLE 2.1. (continued )
Year

Event

1984

Drug Price Competition and P...
34

REGULATION OF HUMAN PHARMACEUTICAL SAFETY

medicine lobby. Flyers decried S.1944 as everything from a communist plot t...
2.2. BRIEF HISTORY OF U.S. PHARMACEUTICAL LAW

35

Ruth Lamb called it ‘‘an opus for the relief of indigent and unemployed...
36

REGULATION OF HUMAN PHARMACEUTICAL SAFETY

about the tragedy. Copeland and Representative Chapman (of Kentucky) presse...
2.2. BRIEF HISTORY OF U.S. PHARMACEUTICAL LAW

37

directed by a third party (the physician). In 1929, ethical pharmaceuti...
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[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
[Shayne cox gad]_drug_safety_evaluation(book_fi.org)
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