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Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 7, 3 Issues, 2020
ISSN: 2213-4778 (Online)
ISSN: 2213-476X (Print)
This journal supports open access
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In the current pandemic scenario, publication process of all articles related to Coronavirus will be expedited, for timely publication of much needed research

Aims & Scope

Applied Clinical Research, Clinical Trials and Regulatory Affairs is an international journal with market leadership in readership and contributions that are scientific, original, relevant, innovative and statistically validated. The journal aims to further bridge the gap in the publication of clinical drug development and regulatory affairs between high growth and potentially growing regions.

The journal Applied Clinical Research, Clinical Trials and Regulatory Affairs publishes innovative, developmental and original research on validated experimental design, methods, representation and interpretation of clinical research and drug trials. Additionally, the journal publishes original research articles, full-length/mini reviews, short communications and thematic journal issues. Published work is based on solid clinical, scientific and statistically relevant results that lead to advancements in clinical medicine including nanomedicine, clinical research, clinical devices, biomedical engineering related to clinical medicine, regulatory affairs and human subject protection in the areas of biological advances, drugs, bio-therapeutics and devices.

Applied Clinical Research, Clinical Trials and Regulatory Affairs

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Volume 7

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Number 2



Editorial   Open Access



Review Article   Open Access

US FDA Warning Letters of CAPA Violations: A Review

, 7(2): 85 - 92

Pavan Deshpande, Rutuja Agawane, Sarath C. Tatikola and Surenahalli G. Vasantharaju*


DOI: 10.2174/2213476X06666191015114427


Review Article   Open Access



Review Article   Open Access



Review Article   Open Access



Review Article   Open Access



Research Article   Open Access



Research Article



Abstracts Ahead of Print

There are currently no Abstracts Ahead of Print available for this journal.

Editor's Choice



A Regulatory Overview of Hip And Knee Joint Replacement Devices

, 2019; 6(3): 212 - 230

Anmol Wadhwa, Sushama Talegaonkar* and Harvinder Popli


DOI: 10.2174/2213476X06666190823142403



Implementation of Quality by Design: A Review

, 2019; 6(2): 99 - 111

Deepika Purohit, Manisha Saini, Parijat Pandey, Swagat Tripathy and Harish Dureja*


DOI: 10.2174/2213476X06666190117120029



Therapeutic Potential of Probiotics: A Ray of Hope or Nightmare?

, 2019; 6(1): 18 - 33

Malika Arora, Navdeep Kaur, Parveen Bansal* and Ashish Baldi


DOI: 10.2174/2213476X06666190126161931



Nanotechnology: A Modern Contraption in Cosmetics and Dermatology

, 2018; 5(3): 147 - 158

Neelam Sharma, Sukhbir Singh*, Neha Kanojia, Ajmer Singh Grewal and Sandeep Arora


DOI: 10.2174/2213476X05666180528093905






To Evaluate the Acceptance/Rejection Rate of General Informed Consent in OPD Patients

, 2017; 4(2): 133 - 139

Supreet Kaur Gill, Malika Arora, Vikas Gupta, Sanjay Gupta and Parveen Bansal*


DOI: 10.2174/2213476X04666170619091639



Open Access Articles

First FDA Approved 3D Printed Drug Paved New Path for Increased Precision in Patient Care

, 2020; 7(2): 93 - 103

C. Venkateswara Reddy*, Balamuralidhara V., M.P. Venkatesh and T.M. Pramod Kumar




US FDA Warning Letters of CAPA Violations: A Review

, 2020; 7(2): 85 - 92

Pavan Deshpande, Rutuja Agawane, Sarath C. Tatikola and Surenahalli G. Vasantharaju*





Medical Device Rules - 2017, India: An Insight

, 2020; 7(2): 126 - 134

Damini Sharma and Amrish Chandra *







Assessment of the Quality of Randomized Clinical Trials Published by Iranian Researchers in Persian Internal Journals in 2014

, 2020; 7(1): 65 - 70

Mohammad Rafiei, Awat Feizi, Seyyed P. Shariatpanahi, Iman Hamraz and Danial Habibi*





Overview of Periodic Safety Update Reports: Where Have We Reached?

, 2020; 7(1): 4 - 11

Ruchika Sharma, Kamal Kant and Anoop Kumar*






Biosimilars Regulation in the United States and FDA Approved Biosimilars from 2015-2018

, 2020; 7(1): 12 - 29

Vikram, Aakash Deep*, Manita, Avtar C. Rana, Monu Yadav and Rakesh K. Marwaha





A Regulatory Overview of Hip And Knee Joint Replacement Devices

, 2019; 6(3): 212 - 230

Anmol Wadhwa, Sushama Talegaonkar* and Harvinder Popli





Most Cited Articles

Current Trends in Globalization of Industry-Sponsored Clinical Trials

, 2014; 1(1): 56-66.

Vladimir Misik, Rachel V. Brady, Martin Bolecek and Heinrich Klech


DOI: 10.2174/2213476X01666131111191016


Regulating Clinical Trials in Saudi Arabia

, 2014; 1(1): 2-9.

SA. Bawazir, H. Hashan, A. Al Hatareshah, A. Al Ghamdi and K. Al Shahwan


DOI: 10.2174/2213476X01666140321182641


A Concept for Clinical Research Triggered by Suggestions from Systematic Reviews About Adjunctive Antibiotics

, 2014; 1(1): 43-50.

Inga Harks, Dag Harmsen, Martina Gravemeier, Karola Prior, Raphael Koch, Stephan Doering, Gregor Petersilka, Thomas Weniger, Peter Eickholz, Thomas Hoffmann, Ti-Sun Kim, Thomas Kocher, Jorg Meyle, Peter Purucker, Ulrich Schlagenhauf and Benjamin Ehmke


DOI: 10.2174/2213476X01666140327211914






Most Accessed Articles





Biosimilars Regulation in the United States and FDA Approved Biosimilars from 2015-2018

, 2020; 7(1): 12-29.

Vikram, Aakash Deep*, Manita, Avtar C. Rana, Monu Yadav and Rakesh K. Marwaha


DOI: 10.2174/2213476X06666190213141839




Regulating Clinical Trials in Saudi Arabia

, 2014; 1(1): 2-9.

SA. Bawazir, H. Hashan, A. Al Hatareshah, A. Al Ghamdi and K. Al Shahwan


DOI: 10.2174/2213476X01666140321182641



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