Overview of Regulatory Guidelines on Impurities and Genotoxic Impurities

2014 ◽  
pp. 1-64
Author(s):  
Heewon Lee ◽  
Debie Hoivik
Keyword(s):  
Regulatory Guidelines ◽  
Genotoxic Impurities

scholarly journals GENOTOXIC IMPURITIES: AN IMPORTANT REGULATORY ASPECT

2020 ◽  
pp. 10-25 ◽  
Author(s):  
ANITA R POUNIKAR ◽  
MILIND J UMEKAR ◽  
KRISHNA R GUPTA
Keyword(s):  
In Silico ◽  
High Performance ◽  
Drug Application ◽  
Data Interpretation ◽  
Regulatory Agencies ◽  
Chromosomal Structure ◽  
New Drug ◽  
Regulatory Guidelines ◽  
Genotoxic Impurities ◽  
New Drug Application

Genotoxins are agents/carriers such as chemical or radiation that can cause the damage to DNA or chromosomal structure, thereby causing mutations and the process are called as genotoxicity. Identification and understanding of genotoxins at a primary stage of drug development would enable us to prevent the potential damage that can be caused by these genotoxic agents. Various regulatory agencies such as International Council for Harmonization and EMEA, USFDA, European Pharmacopeia guidance, guidance for oncology products provide guidelines to limits the level of impurities in drug substances and drug products. Nowadays, conventional protocol of isolation, various spectral analysis high-performance liquid chromatography (LC), Fourier transform infrared to on-line analysis using modern, sophisticated hyphenated tools, like gas chromatography-mass spectroscopy, LC-MS so on, as well as modern software based in silico drug designs are extensively used by industry, research, and development areas and also there is tremendous increase in publications in the literature involving their use. Our review article focused on the various regulatory guidelines, application of hyphenated tools, and in silico techniques in genotoxic impurity and degradation product profiling of small molecules. A brief explanation is made on possible pitfalls in the experimentation and data interpretation. From this review, it concluded that there are various countries having their own regulatory agencies and regulatory guidelines for drug approvals, which may be followed by applying new chemical entities the new drug application title (NDA) in new drug application as well as there are various conventional to modern software based techniques to quantification of genotoxic impurities.

3D Printing in Pharmaceuticals: Regulatory Perspective

2019 ◽  
Vol 24 (42) ◽  
pp. 5081-5083 ◽  
Author(s):  
Mohd. A. Mirza ◽  
Zeenat Iqbal
Keyword(s):  
New Technologies ◽  
Pharmaceutical Product ◽  
Regulatory Agencies ◽  
Major Research ◽  
Data Bases ◽  
Drug Products ◽  
Regulatory Perspective ◽  
Regulatory Guidelines ◽  
Recent Developments ◽  
Technical Issues

Background: The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, design and delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employed in fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into the pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of“personalized medicine”. Methods: Data bases and search engines of regulatory agencies like USFDA and EMA have been searched thoroughly for relevant guidelines and approved products. Other portals like PubMed and Google Scholar were also ferreted for any relevant repository of publications are referred to wherever required. Results: So far only one pharmaceutical product has been approved in this category by USFDA and stringent regulatory agencies are working over the drafting of guidelines and technical issues. Major research of this category belongs to the academic domain. Conclusion: It is also implicit to such new technologies that there would be numerous challenges and doubts before these are accepted as safe and efficacious. The situation demands concerted and cautious efforts to bring in foolproof regulatory guidelines which would ultimately lead to the success of this revolutionary technology.

Upcoming Drifts In Bio-Similars

2020 ◽  
Vol 15 ◽  
Author(s):  
Geeta Aggarwal ◽  
Manju Nagpal ◽  
Ameya Sharma ◽  
Vivek Puri ◽  
Gitika Arora Dhingra
Keyword(s):  
Metabolic Diseases ◽  
Market Competition ◽  
Current Status ◽  
Medicinal Products ◽  
The Past ◽  
Biologic Activity ◽  
Emerging Trends ◽  
Regulatory Guidelines ◽  
Food Drug Administration ◽  
Insight Into

Background: Biopharmaceuticals such as Biologic medicinal products have been in clinical use over the past three decades and have benefited towards the therapy of degenerative and critical metabolic diseases. It is forecasted that market of biologics will be going to increase at a rate of 20% per year, and by 2025, more than ˃ 50% of new drug approvals may be biological products. The increasing utilization of the biologics necessitates for cost control, especially for innovators products that have enjoyed a lengthy period of exclusive use. As the first wave of biopharmaceuticals is expired or set to expire, it has led to various opportunities for the expansion of bio-similars i.e. copied versions of original biologics with same biologic activity. Development of biosimilars is expected to promote market competition, meet worldwide demand, sustain the healthcare systems and maintain the incentives for innovation. Methods: Appraisal of published articles from peer reviewed journals, PubMed literature, latest news and guidelines from European Medicine Agency, US Food Drug Administration (FDA) and India are used to identify data for review. Results: Main insight into the quality requirements concerning biologics, current status of regulation of biosimilars and upcoming challenges lying ahead for the upgrading of marketing authorization of bio-similars has been incorporated. Compiled literature on therapeutic status, regulatory guidelines and the emerging trends and opportunities of biosimilars has been thoroughly stated. Conclusion: Updates on biosimilars will support to investigate the possible impact of bio-similars on healthcare market.

Pain-Prescription Differences - An Analysis of 500,000 Discharge Summaries

2019 ◽  
Vol 11 (1) ◽  
pp. 58-66 ◽  
Author(s):  
Saskia Preissner ◽  
Vishal B. Siramshetty ◽  
Mathias Dunkel ◽  
Paul Steinborn ◽  
Friedrich C. Luft ◽  
...  
Keyword(s):  
Pain Therapy ◽  
Opioid Analgesic ◽  
Developed Countries ◽  
Discharge Summary ◽  
Pain Reliever ◽  
Regulatory Guidelines ◽  
The Usa ◽  
Prescription Rates ◽  
East West ◽  
Discharge Summaries

Background: Pain-relief prescriptions have led to an alarming increase in drug-related abuse. Objective: In this study, we estimate the pain reliever prescription rates at a major German academic hospital center and compare with the nationwide trends from Germany and prescription reports from the USA. Methods: We analysed >500,000 discharge summaries from Charité, encompassing the years 2006 to 2015, and extracted the medications and diagnoses from each discharge summary. Prescription reports from the USA and Germany were collected and compared with the trends at Charité to identify the frequently prescribed pain relievers and their world-wide utilization trends. The average costs of pain therapy were also calculated and compared between the three regions. Results: Metamizole (dipyrone), a non-opioid analgesic, was the most commonly prescribed pain reliever at Charité (59%) and in Germany (23%) while oxycodone (29%), a semi-synthetic opioid, was most commonly ordered in the USA. Surprisingly, metamizole was prescribed to nearly 20% of all patients at Charité, a drug that has been banned for safety reasons (agranulocytosis) in most developed countries including Canada, United Kingdom, and USA. A large number of prospective cases with high risk for agranulocytosis and other side effects were found. The average cost of pain therapy greatly varied between the USA (125.3 EUR) and Charité (17.2 EUR). Conclusion: The choice of pain relievers varies regionally and is often in disagreement with approved indications and regulatory guidelines. A pronounced East-West gradient was observed with metamizole use and the opposite with prescription opioids.

A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

2020 ◽  
Vol 7 (3) ◽  
pp. 162-176
Author(s):  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
Vikas Rathee
Keyword(s):  
Regulatory Requirements ◽  
Health Value ◽  
Drug Products ◽  
Registration Process ◽  
Potential Market ◽  
Regulatory Guidelines ◽  
Cis Countries ◽  
In Cis ◽  
Regulatory Organization ◽  
Country Specific

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL

2016 ◽  
Vol 4 (2) ◽  
pp. 1-9
Author(s):  
Lincy Joseph ◽  
Mathew George ◽  
Kalpesh K Malaviya ◽  
Kalpesh K Malaviya ◽  
Bincy K Chacko ◽  
...  
Keyword(s):  
Generic Drug ◽  
Drug Approval ◽  
Evaluation Agency ◽  
Approval Process ◽  
Registration Process ◽  
Regulatory Guidelines ◽  
Food Drug Administration ◽  
Government Websites ◽  
Drug Approval Process ◽  
Regulatory Sites

This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. Based on the information collected from various sources such as regulatory sites, Government websites,discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, aclear picture on the generic drug approval and registration process of each country was drawn. The differentauthorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) ofUSA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval andregistration process in the respective countries. After analysing the various requirements for the generic drug approvalin the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not welldefined. But FDA gives very much well defined requirements. 

scholarly journals Application of Smartphone Technologies in Disease Monitoring: A Systematic Review

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 889
Author(s):  
Jeban Chandir Moses ◽  
Sasan Adibi ◽  
Sheikh Mohammed Shariful ◽  
Nilmini Wickramasinghe ◽  
Lemai Nguyen
Keyword(s):  
Technology Acceptance ◽  
Electronic Monitoring ◽  
Self Management ◽  
Disease Monitoring ◽  
Eating Behaviours ◽  
Chronic Patients ◽  
Non Invasive ◽  
Regulatory Guidelines ◽  
Critical Issues ◽  
Weight Management Programs

Technologies play an essential role in monitoring, managing, and self-management of chronic diseases. Since chronic patients rely on life-long healthcare systems and the current COVID-19 pandemic has placed limits on hospital care, there is a need to explore disease monitoring and management technologies and examine their acceptance by chronic patients. We systematically examined the use of smartphone applications (apps) in chronic disease monitoring and management in databases, namely, Medline, Web of Science, Embase, and Proquest, published from 2010 to 2020. Results showed that app-based weight management programs had a significant effect on healthy eating and physical activity (p = 0.002), eating behaviours (p < 0.001) and dietary intake pattern (p < 0.001), decreased mean body weight (p = 0.008), mean Body Mass Index (BMI) (p = 0.002) and mean waist circumference (p < 0.001). App intervention assisted in decreasing the stress levels (paired t-test = 3.18; p < 0.05). Among cancer patients, we observed a high acceptance of technology (76%) and a moderately positive correlation between non-invasive electronic monitoring data and questionnaire (r = 0.6, p < 0.0001). We found a significant relationship between app use and standard clinical evaluation and high acceptance of the use of apps to monitor the disease. Our findings provide insights into critical issues, including technology acceptance along with regulatory guidelines to be considered when designing, developing, and deploying smartphone solutions targeted for chronic patients.

scholarly journals Challenges for Evaluation of the Safety of Engineered Nanomaterials

2021 ◽  
Vol 43 (1) ◽  
pp. 4-7
Author(s):  
Linda J. Johnston ◽  
Norma Gonzalez-Rojano ◽  
Kevin J. Wilkinson ◽  
Baoshan Xing
Keyword(s):  
Rapid Development ◽  
Sustainable Use ◽  
Cost Effective ◽  
Engineered Nanomaterials ◽  
Full Potential ◽  
Effective Strategies ◽  
Toxicological Studies ◽  
Regulatory Guidelines ◽  
Significant Effort ◽  
Safe By Design

Abstract Nanotechnology has developed rapidly in the last two decades with significant effort focused on the development of nano-enabled materials with new or improved properties that offer solutions for current world challenges. The commercialization of products containing engineered nanomaterials (ENM) has progressed much more rapidly than the development of practical approaches to ensure their safe and sustainable use. The lack of adequate detection and characterization techniques and reproducible and validated methods for toxicological studies have been identified as major limitations. The rapid development of ENM of increasing complexity and diversity and concerns over the adequacy of existing regulations also contribute to safety concerns with these materials. The full potential of nanotechnology can only be realized when feasible, cost-effective strategies to ensure a safe-by-design approach, effective risk assessment approaches and appropriate regulatory guidelines are in place.

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