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Applied Drug Research, Clinical Trials and Regulatory Affairs - Online First
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Upholding Data Integrity in the Pharmaceutical Industry
Authors: Md Moidul Islam, Jyotibikash Kalita and Sarjana RaikwarAvailable online: 14 January 2025More Less
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Impact of Contract Research Organizations on Pharmaceutical Industries: A Review
Authors: Neeta Solanki, Jaya Verma, Satyender Kumar, Seema, Jyoti Mundlia, Rajesh Saini and Sapna SainiAvailable online: 10 December 2024More LessContract Research Organizations are bodies that offer research and development services on a contract basis to the pharmaceutical, biotechnology, medical device, and other industries. These organizations offer a wide range of services to support the drug discovery, development, and commercialization process. Initially, CROs begin with clinical trial management facilities and assisting sponsors with cli Read More
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Compliance with Regulatory Standards: A Comprehensive Review on Ocimum sanctum (Tulsi)
Authors: Sanyam Sharma, Subh Naman, Jayesh Dwivedi, Mahendra Singh Ashawat, Arun Chandan and Ashish BaldiAvailable online: 06 November 2024More LessIn response to the surging global demand for medicinal products, the herbal industry faces significant challenges in ensuring the quality of herbal formulations. Regulatory bodies, actively set wanted acceptance limits to different parameters and tries to uphold quality standards. However, the complexities of herbal manufacturing, characterized by batch-to-batch variations and heavy metal residues, pose formidable obstacles. Read More
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Navigating Biosimilar Regulatory Pathways in Emerging Markets: Insights from Brics Nations
Authors: Niraj Patil, Animesh Ranjan, Gaurav, Debanjan Mukherjee, Brajesh Kumar Panda, Diksha, Komal, Raj Kumar Narang and Amandeep SinghAvailable online: 06 November 2024More LessThis comprehensive review delves into the intricate landscape of biosimilars, offering a nuanced exploration of their background, pivotal role in emerging markets like BRICS, and the multifaceted considerations spanning regulatory, quality, manufacturing, pricing, reimbursement, intellectual property, pharmacovigilance, and future trends. The backdrop on biosimilars unravels their significance as a transformative force in hea Read More
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Assessment and Monitoring of Adverse Drug Reactions at a Tertiary Care Hospital
Authors: Manvi Sharma, Prince P. George, Ranjeet Kumar, Amit Sharma and Rojin G. RajAvailable online: 07 October 2024More LessBackground Incidences of adverse drug reactions were reported through spontaneous reporting at an ADR monitoring unit in a tertiary care hospital. Aims This study was conducted to describe the distribution pattern of adverse drug reaction (ADR). Objective The objective of this study was to monitor and report the adverse drug reactions (ADRs) occurring in a tertiary care hospital and to evaluate the incidence, causalit Read More
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