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COMPARATIVE STUDY ON NEW DRUG APPLICATION PROCEDURE IN US, EU & INDIA: NDA Process in Different Countries - Softcover

Rao, S. Venkateswara; Padmalatha, K.; Hemalatha, B.

 
9786204748283: COMPARATIVE STUDY ON NEW DRUG APPLICATION PROCEDURE IN US, EU & INDIA: NDA Process in Different Countries
Softcover
ISBN 10: 6204748289 ISBN 13: 9786204748283
Verlag: LAP LAMBERT Academic Publishing, 2022

Inhaltsangabe

Developing a new drug requires a great amount of research work in chemistry, manufacturing, preclinical science, and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness, and quality control of a new drug product to serve public health. Every country has its own regulatory authority, which is responsible to enforce the rules & regulations and issuing guidelines to regulate the marketing of the drugs. This book focuses on the New Drug Application (NDA) approval process in different countries like the USA, Europe, and India.

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Über die Autorin bzw. den Autor

Dr. S. Venkateswar Rao, having 14 years of teaching experience and presently working as professor & HoD department of Pharmaceutics, Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada, Andhra Pradesh.

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Verlag
LAP LAMBERT Academic Publishing
Erscheinungsdatum
2022
Sprache
Englisch
ISBN 10 
6204748289
ISBN 13 
9786204748283
Einband
Taschenbuch
Anzahl der Seiten
124
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
info@bod.de
info@bod.de

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