Page 14 - Chiral Separation Techniques

XIV Contents

13.2.4.1 Single Enantiomer 328
13.2.4.2 Racemate 328
13.2.4.3 New Single Enantiomer from Approved Racemate or New Racemate
from Approved Single Enantiomer 328
13.2.4.4 Nonracemic Mixture from Approved Racemate or Single
Enantiomer 328
13.2.4.5 Abridged Applications 329
13.3 Requirements in the United States 329
13.3.1 Introduction 329
13.3.2 Policy Statement for the Development of New Stereoisomeric
Drugs 329
13.3.3 Chemistry, manufacturing and controls 330
13.3.3.1 Methods and Specifications 331
13.3.3.2 Stability 331
13.3.3.3 Impurity Limits 331
13.3.3.4 Pharmacology/Toxicology 331
13.3.4 Developing a Single Enantiomer after a Racemate is Studied 332
13.3.4.1 Clinical and Biopharmaceutical 332
13.3.5 Other Relevant FDA Guidance 332
13.4 Requirements in Japan 333
13.5 Guidelines from the International Conference on Harmonization 335
13.5.1 Introduction 335
13.5.2 Specifications and Tests 335
13.5.3 Impurities 338
13.5.4 Analytical Validation 339
13.5.5 Common Technical Document 340
12.6 The Effect of Regulatory Guidelines 340
12.7 Concluding Remarks 342
References 342

Index 343