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35 articles for “regulatory guidelines”
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A Comprehensive Exploration of Method Validation and Development in Pharmaceutical Analysis: Focus on Vortioxetine Analysis
Abstract: The pharmaceutical industry relies on rigorous method validation to ensure the accuracy, precision, and reliability of analytical techniques employed in drug testing and quality control. This comprehensive exploration delves into the validation parameters and guidelines essential for method validation, emphasizing accuracy, precision, linearity, detection and quantitation limits, specificity, range, robustness, and ruggedness. Validation plays a pivotal role in guaranteeing high-quality products, adhering to good manufacturing practices (GMP), and optimizing manufacturing …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 46–52 Read article
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Striking A Balance: Ethical Guidelines for A.I. Integration in Mental Health Services
Abstract: Introduction: Artificial Intelligence (AI) integration in mental health services presents opportunities and challenges. This study examines ethical considerations and proposes guidelines for responsible AI implementation in mental healthcare. The rapid advancement of AI technologies has sparked both excitement and concern within the mental health community, necessitating a thorough examination of their potential benefits and risks. By addressing these ethical considerations, this research aims to contribute to the development of a …
Published in International Journal of Behavioral Sciences · Vol. 2, Issue 1, 2025 · pp. 8–15 Read article
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Innovations in Oral Drug Delivery: Challenges and Opportunities
Abstract: The advancement of novel drug manufacturing technologies offers immense opportunities for innovation but brings regulatory complexities that must be addressed to ensure successful implementation. Early and frequent collaboration with the FDA is fundamental for overcoming these challenges. The establishment of the FDA’s Emerging Technology Team has been pivotal in fostering open dialogue, brainstorming, and feedback between regulators and innovators, reducing the likelihood of unexpected setbacks that could jeopardize projects. Mechanisms …
Published in Trends in Drug Delivery · Vol. 12, Issue 1, 2025 · pp. 31–43 Read article
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QSAR Modeling Techniques: A Comprehensive Review of Tools and Best Practices
Abstract: Quantitative Structure–Activity Relationship (QSAR) modeling has become an essential tool in drug discovery, toxicity assessment, and environmental chemistry. By correlating chemical structure with biological activity or toxicity, QSAR enables the prediction of compound behavior without extensive experimental testing. This approach not only saves time and resources but also supports ethical practices by reducing reliance on animal studies. The evolution of QSAR from basic linear models to advanced machine learning and …
Published in International Journal of Cheminformatics · Vol. 3, Issue 1, 2025 · pp. 56–63 Read article
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Revamping of Pharmaceutical Manufacturing Processes
Abstract: The pharmaceutical sector is entering a new era marked by technological advancements and an emphasis on sustainability and efficiency. A commitment to compliance can help boost consumer confidence and regulatory approval. This abstract explores the multifaceted approach to revamping pharmaceutical manufacturing processes, encompassing technological integration, regulatory compliance, and sustainability initiatives. Technological advancements, including automation, data analytics, and artificial intelligence, are playing a pivotal role in streamlining manufacturing operations. These innovations …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 38–44 Read article
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A Study on “Clean" in Beauty: A Machine LearningApproach to Ingredient Transparency and ConsumerTrust
Abstract: The burgeoning "clean beauty" market, while driven by consumer demand for safer and more sustainable products, is plagued by ambiguous definitions and the pervasive challenge of "greenwashing". This ambiguity hinders informed consumer choices and complicates brand authenticity. This study addresses these complexities by developing a novel machine learning (ML) framework designed to objectively analyze cosmetic ingredient lists, classify products based on their "cleanliness" profile, and identify key ingredient attributes that …
Published in Recent Trends in Cosmetics · Vol. 3, Issue 1, 2026 · pp. 1–12 Read article
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Data Integrity Best Practices in Pharmaceutical Quality Assurance: A Thorough Review
Abstract: Data integrity stands as a linchpin in the reliability and trustworthiness of systems involved in handling, analyzing, and retrieving information, safeguarding the accuracy and consistency of data from inception to disposal. This paper delves into the multifaceted realm of data integrity, encompassing its definition, pivotal importance, regulatory underpinnings, core principles, and practical implementation strategies. A comprehensive exploration of regulatory guidelines, including ICH Q7, EU Annexure 11, and FDA regulations, underscores …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 22–30 Read article
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Speech Therapy in the Digital Age: Telepractice and Remote Interventions
Abstract: In the digital age, advancements in technology have revolutionized various aspects of healthcare, including speech therapy. This study explores the emergence and evolution of telepractice and remote interventions in speech therapy. Telepractice, interchangeably labelled as teletherapy or telehealth, denotes providing speech therapy services remotely using telecommunication technology. Its incorporation into speech therapy has broadened service accessibility, notably benefiting underserved or remote locales. Moreover, it has ensured uninterrupted care delivery during …
Published in Research and Reviews: A Journal of Health Professions · Vol. 14, Issue 1, 2024 · pp. 42–46 Read article
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Antibiotic Residues in Broiler Meat: Challenges for Food Safety, Public Health, and Sustainable Broiler Farming Issues
Abstract: Antibiotic residues in broiler meat pose significant risks to food safety, public health, and the sustainability of poultry farming. The use of antibiotics in broiler production, both for therapeutic and prophylactic purposes, has led to the accumulation of residues in meat, which can contribute to the development of antimicrobial resistance (AMR). This paper explores the various potential sources of antibiotic residues in broiler meat, including feed-related factors, water contamination, injection …
Published in Research and Reviews : A Journal of Life Sciences · Vol. 15, Issue 1, 2025 · pp. 77–90 Read article
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Role of Crispr-Cas9 in Plants
Abstract: The innovative CRISPR Cas9 system has emerged as a game changing genetic engineering tool in years offering levels of precision, efficiency and flexibility in editing the genomes of various organisms, including plants. This summary aims to provide an examination of the role of CRISPR Cas9, in modifying plant genomes highlighting its benefits, drawbacks and possible uses. Thanks to its versatility and user-friendly nature CRISPR Cas9 technology has expedited studies in …
Published in Research and Reviews : A Journal of Biotechnology · Vol. 14, Issue 3, 2024 · pp. 1–10 Read article
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Neurodevelopmental Effects of Cell Tower Radiation in Children: A Longitudinal Study
Abstract: This study investigates the impact of radiation exposure from cell phone towers on the neurodevelopmental outcomes of children aged 0–5 years. A prospective cohort approach was employed to assess key developmental parameters, including Gross Motor Skills, Fine Motor Skills, and sleep disorders. Given the increasing presence of wireless communication infrastructure, understanding its potential effects on early childhood development is crucial for public health.To analyze the collected data, advanced machine learning …
Published in Research and Reviews : Journal of Computational Biology · Vol. 14, Issue 2, 2025 Read article
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Review article on Quality Control in Clinical Trials
Abstract: Quality control (QC) is a critical component in the conduct of clinical trials, ensuring the accuracy, reliability, and credibility of data collected throughout the study. It encompasses a systematic set of procedures designed to monitor trial conduct and data integrity, thus safeguarding the rights, safety, and well-being of participants. This review explores the principles, implementation, and evolving practices of quality control in clinical trials, highlighting its importance across all phases …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 12, Issue 3, 2025 · pp. 01–07 Read article
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A Research on the Additives and Regulatory Requirements for Pediatric Formulation
Abstract: These days, pediatric considerations are incorporated early on in the creation of new medications. The guidelines and policies of European drug regulatory bodies served as the foundation for our investigation. The review comprehensively outlines excipients commonly found in pediatric medicine formulations. It identifies potentially harmful compounds flagged by scientific literature, stressing the necessity of rigorous safety checks, often involving toxicity studies. Excipients included in pediatric databases, like the STEP database, …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 28–45 Read article
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Understanding Significance, Challenges and Barriers in Home-Based Medical Care – A Thematic Review of Literature
Abstract: Home-based medical care (HBMC) is emerging as a cornerstone of modern healthcare, offering a pragmatic solution to the evolving needs of patients. This form of care, which delivers personalized and patient-centric services, catering to individual needs within the familiar environment of their homes, is gaining traction for its ability to improve patient outcomes while simultaneously reducing healthcare costs. This thematic review of the literature aims to shed light on the …
Published in Research and Reviews : A Journal of Life Sciences · Vol. 14, Issue 1, 2024 · pp. 66–71 Read article
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AI-Driven Promotion Platforms: Increasing Customer Engagement in Banking
Abstract: Artificial Intelligence has been in talk since data was considered as an asset. Using this data, prolific information has been extracted to gather detailed information and create datasets. Artificial intelligence is shaping the narrative of the world in the 21st century. It has become a driving force behind innovation, influencing various industries and redefining traditional practices. Artificial intelligence has revolutionized customer engagement strategies across industries, particularly Banking. This study explores …
Published in Journal of Artificial Intelligence Research & Advances · Vol. 12, Issue 1, 2025 · pp. 87–92 Read article
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Comparative Analysis of Sustainable Materials in Road Construction: A Review
Abstract: The immediate need for sustainable infrastructure has driven research into new materials in road construction with the goal of reducing environmental degradation and enhancing resource efficiency. This review is a comparative analysis of four innovative technologies involving industrial and natural waste products: recycled aggregates from construction and demolition (C&D) waste, feldspar powder from lithium mining, stabilized dam sediments using eucalyptus ash, and calcium carbide residue (CCR) blended with dredged sludge. …
Published in Journal of Construction Engineering, Technology & Management · Vol. 15, Issue 3, 2025 · pp. 93–98 Read article
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A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India
Abstract: A major regulatory change in pharmaceutical manufacturing industry in India is the introduction of the updated Schedule M (2023–2024). The aims to compliance the country's Good Manufacturing Practices (GMP) with international quality standards. The review evaluates the Schedule M amendments implementation strategies, industrial impact and regulatory relevance. Legislative texts, official notices, WHO GMP reports, ICH guidelines, guidance documents of CDSCO and peer-reviewed literature were all explored as part of the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 2, 2026 Read article
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Enhanced Management of an Eco-Friendly Ready-Mix Concrete Batching Facility for Superior Concrete Production
Abstract: The construction industry plays a crucial role in the global economy. At the heart of this industry is concrete, a material that is essential for buildings. Ready-mix concrete (RMC) is becoming increasingly favored for its quick setting characteristics and high-quality performance. In India, the rising demand for RMC underscores the importance of strict quality management to mitigate potential structural risks. This study set out to explore how quality management is …
Published in Recent Trends in Civil Engineering & Technology · Vol. 15, Issue 2, 2025 · pp. 25–31 Read article
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Recent Advances in Quality Control and Quality Assurance: Enhancing Pharmaceutical Product Integrity and Compliance
Abstract: The pharmaceutical industry is undergoing a paradigm shift driven by stringent regulatory expectations and the demand for high-quality, safe, and efficacious drug products. Quality Control (QC) and Quality Assurance (QA) serve as the two foundational pillars that ensure pharmaceutical integrity from raw material acquisition through to product release. Traditional QC and QA practices, while effective, have been challenged by complex formulations, biologics, and personalized medicine, requiring innovative methodologies and technologies. …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 2, 2025 · pp. 54–62 Read article
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Nanoformulation Strategies: Emerging Innovations in Drug Delivery Systems
Abstract: Nanotechnology is significantly advancing the pharmaceutical industry by introducing nanosystems that improve drug delivery, therapeutic efficacy, and patient outcomes. Various nanosystems-such as liposomes, dendrimers, polymeric nanoparticles, solid lipid nanoparticles, carbon nanotubes, and metallic nanoparticles-offer benefits like enhanced bioavailability, targeted delivery, improved stability, and reduced side effects. Innovative formulation strategies, including surface functionalization, particle size optimization, and use of biodegradable carriers, support controlled and sustained drug release. Additionally, production in non-aqueous …
Published in International Journal of Toxins and Toxics · Vol. 3, Issue 1, 2026 · pp. 54–67 Read article