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

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

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

Synopsis

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2022
Langue
anglais
ISBN 10 
6204748289
ISBN 13 
9786204748283
Reliure
Broché
Nombre de pages
124
Coordonnées du fabricant
non disponible
Personne responsable
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