PRECLINICAL TOXICOLOGY - Pacific BioLabs

PRECLINICAL TOXICOLOGY

GUIDANCE FOR INDUSTRY ? ICH GUIDANCES

TABLE OF CONTENTS Pacific BioLabs ? Your Partner for Preclinical Safety Testing........................1 Guidance for Industry M3 ? Nonclinical Safety Studies for the

Conduct of Human Clinical Trials for Pharmaceuticals.......................2 ? 13 Guidance for Industry S6 ? Preclinical Safety Evaluation

of Biotechnology-Derived Pharmaceuticals .......................................14 ? 27 The Pacific BioLabs Advantage ....................................................................28 Contact Information .......................................................................................29

T o v i e w t h i s b o o k l e t o n l i n e , p l e a s e v i s i t P a c i f i c B i o L a b s . c o m.

Preclinical Toxicology ? Guidance for Industry

PACIFIC BIOLABS ? YOUR PARTNER FOR PRECLINICAL SAFETY TESTING

As The Service Leader in Bioscience Testing, Pacific BioLabs (PBL) strives to help our clients deliver safe and effective pharmaceuticals to the patients who need them. Well designed and executed preclinical studies are critical to the success of any drug development program. They must reliably assess the safety of a new drug entity, laying the groundwork for clinical trials and ultimately, regulatory approval. Pacific BioLabs interacts closely with our clients, providing quality nonclinical testing results to meet regulatory requirements and guide your drug development decisions. As part of our commitment to our clients, we have prepared a pair of publications that will assist you in planning your preclinical testing program. This publication presents two major ICH guidance documents that directly address safety testing of new pharmaceuticals:

? Guidance M3 ? Nonclincal Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

? Guidance S6 ? Preclinical Safety Evaluation of BiotechnologyDerived Pharmaceuticals

Both documents are presented in their entirety and can be used as references on questions regarding requirements for safety testing of new chemical entities (NCEs). The FDA website contains these two documents along with a variety of other references on regulatory expectations for the nonclinical development of NCEs. Topics include various aspects of safety (e.g. reproductive, carcinogenicity and genotoxicity), ADME (e.g. bioanalytical, pharmacokinetics and toxicokinetics), and safety pharmacology.

PBL's companion publication ? Preclinical Toxicology - Points to Consider in Program Design, is available on our website at . We hope you find these resources useful, and we wish you the best in your continuing quest to develop safe and effective new medicines. Tom Spalding President Pacific BioLabs

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Pacific BioLabs ? The Service Leader in Bioscience Testing

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Preclinical Toxicology ? Guidance M3

GUIDANCE FOR INDUSTRY ? M3

NONCLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS

FOR PHARMACEUTICALS (July 1997 ICH)

Table of Contents

I. INTRODUCTION (1) ........................................................................................ 4 A. Objectives of the Guidance (1.1) .............................................................. 4 B. Background (1.2) ...................................................................................... 4 C. Scope of the Guidance (1.3)...................................................................... 4 D. General Principles (1.4) ............................................................................ 5

II. SAFETY PHARMACOLOGY (2) ..................................................................... 6 III. TOXICOKINETIC AND PHARMACOKINETIC STUDIES (3).........................................6 IV. SINGLE DOSE TOXICITY STUDIES (4) ........................................................ 6 V. REPEATED DOSE TOXICITY STUDIES (5) .................................................. 6

A. Phase I and II Studies (5.1) ....................................................................... 7 B. Phase III Studies (5.2)............................................................................... 7 VI. LOCAL TOLERANCE STUDIES (6) ............................................................... 8 VII GENOTOXICITY STUDIES (7) ....................................................................... 8 VIII CARCINOGENICITY STUDIES (8)................................................................. 9 IX. REPRODUCTION TOXICITY STUDIES (9) ................................................... 9 A. Men (9.1) .................................................................................................. 9 B. Women Not of Childbearing Potential (9.2) ............................................. 9 C. Women of Childbearing Potential (9.3) .................................................... 9 D. Pregnant Women (9.4) ............................................................................ 10 X. SUPPLEMENTARY STUDIES (10) ............................................................... 10 XI. CLINICAL TRIALS IN PEDIATRIC POPULATIONS (11) .......................... 11 XII. CONTINUING EFFORTS TO IMPROVE HARMONIZATION (12) ............ 11 XIII. ENDNOTES (13) ............................................................................................. 12 XIV. REFERENCES (14).......................................................................................... 13

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