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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, all articles related to Coronavirus will be processed on a free, quick track basis, to ensure timely review and 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 1



Biography   Open Access



Preface   Open Access



Review Article (Mini-Review)   Open Access



Review Article   Open Access



Review Article   Open Access



Review Article   Open Access



Research Article   Open Access



Research Article   Open Access



Articles Ahead of Print





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


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


DOI: 10.2174/2213476X07666191226145027
View Abstract





US FDA Warning Letters of CAPA Violations. A Review


Pavan Deshpande, Rutuja Agawane, Sarath Chandra Tatikola and Vasantharaju S. G.*


DOI: 10.2174/2213476X06666191015114427
View Abstract



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



Connected Health: An Open Innovation Perspective

, 2017; 4(1): 55 - 59

Anushree Priyadarshini, Maria Quinlan and Gerardine Doyle


DOI: 10.2174/2213476X04666170106154613



Open Access Articles


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




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

, 2020; 7: 1 - 11 (E-Pub Ahead of Print)

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





A Regulatory Overview of Hip And Knee Joint Replacement Devices

, 2019; 6(3): 212 - 230

Anmol Wadhwa, Sushama Talegaonkar* and Harvinder Popli





Import Need for Wound Care and Burn Dressings in India: A Bioeconomic Challenge

, 2019; 6(3): 182 - 191

Vibhu Yadav, Amit Mittal*, Parikshit Bansal and Sachin K. Singh




Regulation and Clinical Investigation of Medical Device in the European Union

, 2019; 6(3): 163 - 181

Manita, Aakash Deep*, Vikram, Avtar C. Rana and Prabodh C. Sharma




Implementation of Quality by Design: A Review

, 2019; 6(2): 99 - 111

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




Safety of Pharmaceutical Excipients and Regulatory Issues

, 2019; 6(2): 86 - 98

Kanteti V.R.N.S. Ramesh*, Hemant Yadav and Omar Sarheed





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




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