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  • Sagar, Vidya  (4)
  • 2020-2024  (4)
Material
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Years
  • 2020-2024  (4)
Year
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  • 1
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 1 ( 2021-03-16), p. 1-9
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 1 ( 2021-03-16), p. 1-9
    Abstract: Objective Finding the relation between scientific evidence development and regulatory approval of medical devices in existing markets, USA (United states of America) and EU (European Union) Design To understand this relation, we used evidence development of fibrin sealant as a case study. In general fibrin sealant is a good case study because there is a lot of information available about it. A systematic review method based on the Cochrane handbook was used to find the evidence development regarding fibrin sealant. We investigated different indications of fibrin sealant, the year of publication, and the phases in clinical trials. To find the procedures and requirements of the approval for fibrin sealant, we searched the government website of their regulatory agencies FDA (Food and Drug Administration), EMA (European Medicine Agency), and CFDA (China Food and Drug Administration). Results The relation between evidence development and approval, we found that the cumulative publications of fibrin sealant increased almost in a straight line from 1998 to 2019. Regarding the applications of fibrin sealant, in the first four years after 1998, no new applications were approved, the next four years, two applications were approved, in the four years after that, there were four new applications. Conclusions In the first years, the amount of new approved applications is very low, compared to the amount of new publications, but afterwards it goes much faster. Even though fibrin sealant seems to be a Medical Device, the regulatory approval takes time to catch up. For the future research, it would be interesting to also include sales data of fibrin sealant to analyse how sales data influences the medical device companies’ strategies for publication and market approval.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2021
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 1 ( 2022-03-16), p. 23-27
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 1 ( 2022-03-16), p. 23-27
    Abstract: The most sure-fire way to pass MDSAP audit with flying colours is to have an effective Quality Management System (QMS). Having a good QMS will make sure work is correctly documented, kept up to date, and easy to present to an auditor. For regulators too, it means a reduced burden. There is pooling of regulatory resources. The audits are conducted by Auditing Organizations designated by the regulatory bodies. The MDSAP program is expected to improve audit predictability because a standardized audit model has been introduced. Every audit follows the same set of steps. For the first time, a grading system is introduced for noncompliance. This approach helps reduce subjectivity. MDSAP has a very rigid auditing process to ensure the proper market authorizations have been obtained and facility registrations have occurred but not represent Marketing Authorization. Recently proposed greater alignment of FDA Quality System Regulation (QSR) with ISO 13485, would bring US QMS requirements for medical device manufacturers closer in line with quality system requirements in markets such as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the US and other markets.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 3
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 3 ( 2022-09-18), p. 42-53
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 3 ( 2022-09-18), p. 42-53
    Abstract: Introduction: Antithrombotic drugs include antiplatelet, anticoagulant and fibrinolytics. Antithrombotic drugs either block the formation of new clots, or prevent the growth of existing clots or reduce risk of complications from blood clots. These drugs are used in various Cardio and neurological diseases ranging from Angina, stroke to as Dual Antiplatelet Therapy (DAT) in post implantation of permanent medical devices. Antithrombotic drugs have numerous side effects from gastritis, prolonged bleeding, hemorrhage, tachycardia, tinnitus based on the class of drugs. Study design and Objective: Though the undesirable effects of antithrombotic drugs are well established in controlled trails, there were rare studies in Real world population. Hence a prospective observational study was under taken to understand the undesirable effects in a Tertiary hospital in India and analyze the pattern based on age, gender, intended and indications of use and dosage regimen. The undesirable effects of Aspirin, Heparin and Clopidogrel were studied in 92 patients over a period of 6 months. Results and Discussion: In the current study there were 8 cases were heparin was indicated and 50% of the patients complained of haemorrhage / bleeding and in 2 cases there is heavy bleeding during cut wounds. All this cases were found in patients where Heparin is used in Cardiology and neurological diseases and old age group on different indications of use. In 60 patients who are on Aspirin therapy 43 patients are in cardiology and 17 in neurological treatment. Most of the indications are for CAD, Myocardial Infraction (MI) and Angina. Important undesirable effects noted in the present study include SOB-9 patients, Tachycardia- 5, Blood in stools-4 patients, Tinnitus -3 patients and Ulcers in 3 patients. Of the 92 cases, Clopidogrel was prescribed for different indications of use in 24 patients. Of them 19 patients are in cardiology and 5 patients are in neurology treatment. Most commonly patients were diagnosed with MI, unstable angina and CVA Ischemic stroke, with observed undesirable effects like prolonged bleeding, dyspepsia, headache, indigestion, heart burn and tachycardia. The study clearly shows that prolonged bleeding was observed in 40% of the patients on clopidogrel mainly in segment with higher doses and on co-medication Conclusion: The present study has shown similar undesirable effects evidenced in controlled clinical trials. However, the study indicates Intravenous administration of Heparin is advised than subcutaneous route and need for larger studies to substantiate the same. It is also recommended that patients on Aspirin should be recommended for low dose mainly in indications related to cardiovascular diseases than higher dosed. Most of the adverse effects are found in patients taking more than 75 mg and BID and TID. It could be related to dose induced effects and also the includes the age factor as most of them are geriatrics and not on anti-ulcer drugs. The study clearly shows that prolonged bleeding was observed in 40% of the patients on clopidogrel mainly in segment with higher doses and on co-medication. A case was reported on overdose of Clopidogrel which resulted in abnormalities in platelet aggregation that required emergency medical care.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 4
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 4 ( 2021-12-24), p. 33-36
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 4 ( 2021-12-24), p. 33-36
    Abstract: Under the new European Union Medical Device Regulation (EU MDR), framed by Medical Device Coordination Group (MDCG), for each device manufacturers must have a documented risk management plan, identify and analyse the known and foreseeable hazards, estimate and evaluate the associated risks and eliminate or control those risks. In contrast with the MDD, the new EU MDR contains an explicit obligation in the new Article 10 (2), that manufacturers establish, document, implement and maintain a system for risk management. The detailed requirements of which are listed in the new Annex I Chapter I. Compared to MDD there is more emphasis on Post Market Surveillance (PMS) activities with the inclusion of European Databank or European Database for Medical Devices (EUDAMED) and mandatory submission of Periodic Safety Update Report (PSUR) to all the actors in the possession with the medical devices. A poll conducted by Aegis Lifesciences Pvt. Ltd, Ahmedabad, India concludes that the relevant annexures and sections in MDR 2017/745 have more emphasis on PMS, Vigilance, PSUR, EUDAMED, tracking, Implantation card etc. that are directed in regard to the safety of the Medical Device.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2021
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
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