Vol 3 No 1 (2015): VOLUME 3, ISSUE 1, 2015 | International Journal of Drug Regulatory Affairs

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Research

STATUS OF A---T POLYMORPHISM IN EXON II OF KINASE INSERT DOMAIN GENE IN WOMEN WITH PREMATURE OVARIAN FAILURE

RGB Ali H. Hasan, Sujatha M.

Pages 92-95
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Review

CLINICAL TRIAL IN INDIA: RISE AND FALL

Chitral Kulshreshtha, M P Venkatesh, K Shrisha, Pramod T.M. Kumar, Pramod T.M. Kumar

Pages 1-13
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THE PATH OF PERSONALIZED MEDICINE: REGULATORY PERSPECTIVE

Chitral Kulshreshtha, Venkatesh M. P., Pramod Kumar T.M.

Pages 14-29
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LYOPHILIZATION - PROCESS AND OPTIMIZATION FOR PHARMACEUTICALS

Deepak Bisht, Zeenat Iqbal

Pages 30-40
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ADVANCES IN THE REVIEW OF GENERIC DRUG APPLICATIONS BY UNITED STATES FOOD AND DRUG ADMINISTRATION, A REGULATORY PERSPECTIVE IN THE ERA OF GDUFA (GENERIC DRUG USER FEE AMENDMENT 2012)

Lakshmi Kanth Maddela, Insukh Oh

Pages 41-61
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REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND

Achin Jain, Venkatesh M. P., Raja Mohan Reddy.G, Pramod Kumar T.M.

Pages 62-74
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COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA

Dinesh Chandra Konuri, Mamillapalli S., A. Elphine P., Brahma S.R. Desu

Pages 75-87
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MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET

Bhave C., Dolhare N., J. K. Badjatya

Pages 88-91
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