Regulatory Requirements and Innovation: A Comparison of Stability Study in the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC)

Reshma Pushpa Murali; Lovely Joylein Castelino; Ravi Gundadka Shriram; Akhilesh Dubey

doi:10.5530/ijpi.2020.3.48

Regulatory Requirements and Innovation: A Comparison of Stability Study in the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC)

International Journal of Pharmaceutical Investigation ◽

10.5530/ijpi.2020.3.48 ◽

2020 ◽

Vol 10 (3) ◽

pp. 263-267

Author(s):

Reshma Pushpa Murali ◽

Lovely Joylein Castelino ◽

Ravi Gundadka Shriram ◽

Akhilesh Dubey

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Gulf Cooperation Council ◽

Stability Study ◽

Regulatory Requirements ◽

United States Food ◽

States Food

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Developing Drugs for Prevention of Chemotherapy-Induced Nausea and Vomiting: Draft Guidance from the United States Food and Drug Administration

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-21-1941 ◽

2021 ◽

pp. clincanres.1941.2021

Author(s):

Erica Lyons ◽

Charles Line ◽

Jessica J Lee

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Nausea And Vomiting ◽

Draft Guidance ◽

United States Food ◽

States Food

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Effects of hypoxia and glutathione depletion on hemoglobin- and myoglobin-mediated oxidative stress toward endothelium1The opinions and assertions contained herein are the scientific views of the authors and are not to be construed as policy of the United States Food and Drug Administration or the United States Army.1

Biochimica et Biophysica Acta (BBA) - Molecular Cell Research ◽

10.1016/s0167-4889(99)00163-9 ◽

2000 ◽

Vol 1495 (2) ◽

pp. 150-159 ◽

Cited By ~ 28

Author(s):

Felice D’Agnillo ◽

Francine Wood ◽

Carlos Porras ◽

Victor W. Macdonald ◽

Abdu I. Alayash

Keyword(s):

Oxidative Stress ◽

United States ◽

United States Army ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Glutathione Depletion ◽

United States Food ◽

States Food

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The Regulation of Drug Products by the United States Food and Drug Administration

The Textbook of Pharmaceutical Medicine ◽

10.1002/9780470987391.ch20 ◽

2007 ◽

pp. 565-601

Author(s):

Peter Barton Hutt

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Drug Products ◽

United States Food ◽

States Food

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The United States Food and Drug Administration and ICH Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-8 ◽

2004 ◽

pp. 57-97

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Good Manufacturing Practice ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

United States Food ◽

States Food

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Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug Applications and Biologic License Applications to the United States Food and Drug Administration

Comprehensive Biotechnology ◽

10.1016/b978-0-444-64046-8.00178-6 ◽

2019 ◽

pp. 473-486

Author(s):

K. Lee

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Regulatory Aspects ◽

New Drug ◽

United States Food ◽

States Food

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The United States Food and Drug Administration

Cobert's Manual of Drug Safety and Pharmacovigilance ◽

10.1142/9789813278851_0008 ◽

2019 ◽

pp. 59-77 ◽

Cited By ~ 1

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

United States Food ◽

States Food

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Regulatory science: a special update from the United States Food and Drug Administration

Toxicology Letters ◽

10.1016/s0378-4274(99)00152-6 ◽

2000 ◽

Vol 111 (3) ◽

pp. 199-202 ◽

Cited By ~ 19

Author(s):

Kuei-Meng Wu ◽

Joseph G. DeGeorge ◽

Aisar Atrakchi ◽

Estella Barry ◽

Anita Bigger ◽

...

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Regulatory Science ◽

United States Food ◽

States Food

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Prognostic Implication of the United States Food and Drug Administration-defined BCG-unresponsive Disease

European Urology ◽

10.1016/j.eururo.2018.09.028 ◽

2019 ◽

Vol 75 (1) ◽

pp. 8-10 ◽

Cited By ~ 11

Author(s):

Roger Li ◽

William B. Tabayoyong ◽

Charles C. Guo ◽

Graciela M. Nogueras González ◽

Neema Navai ◽

...

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Prognostic Implication ◽

United States Food ◽

States Food

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Nonclinical Development of Radiopharmaceuticals: Regulatory Considerations for the United States Food and Drug Administration

From Morphological Imaging to Molecular Targeting ◽

10.1007/978-3-662-07310-0_8 ◽

2004 ◽

pp. 151-165

Author(s):

S. Wilson

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

United States Food ◽

States Food

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Qualification of a non-animal vaginal irritation method admitted as nonclinical assessment model (NAM) in the Incubator Phase of the United States Food and Drug Administration (US FDA) Medical Devices Development Tool (MDDT)

Toxicology in Vitro ◽

10.1016/j.tiv.2019.104680 ◽

2020 ◽

Vol 62 ◽

pp. 104680 ◽

Cited By ~ 1

Author(s):

G.-E. Costin ◽

E. Hill ◽

J. Brown ◽

A.J. Clippinger

Keyword(s):

United States ◽

Drug Administration ◽

Medical Devices ◽

Food And Drug Administration ◽

The United States ◽

Assessment Model ◽

Development Tool ◽

United States Food ◽

States Food ◽

Us Fda

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