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Regulatory Guide for Drug Development
from C.H.I.P.S.

New Drug Development
Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics
edited by Chandrahas G. Sahajwalla

New Drug Development helps those new to the world of pharmaceutical development reduce costs, save time, and attain straightforward guidance through each step of the drug approval process— acquainting readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than 40 respected officials from agencies around the globe.

Contents

  • Introduction to Drug Development and Regulatory Decision-Making
  • Evolution of Drug Development and its Regulatory Process
  • Regulatory Bases for Clinical Pharmacology and Biopharmaceutics Information in a New Drug Application
  • New Drug Application Content and Review Process for Clinical Pharmacology and Biopharmaceutics
  • In-Vitro Drug Metabolism Studies During Development of New Drugs
  • Drug Transporters
  • Principles, Issues, and Applications of Interspecies Scaling
  • Analytical Method Validation
  • Studies of the Basic Pharmacokinetic Properties of a Drug: A Regulatory Perspective
  • Surrogate Markers in Drug Development
  • Population Pharmacokinetic and Pharmacodynamic Analysis
  • Scientific and Regulatory Considerations for Studies in Special Population
  • Conducting Clinical Pharmacology Studies in Pregnant and Lactating Women

Index

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New Drug Development
Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics
edited by Chandrahas G. Sahajwalla

500 pages • $228.95 + shipping
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