Raju Boyapally

Associate Scientist-Toxicology at GV Research Platform (GVRP)
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Contact Information
us****@****om
(386) 825-5501
Location
Hyderabad, Telangana, India, IN
Skills

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Credentials

  • Registered Pharmacist
    Telangana State Pharmacy Council
    Aug, 2023
    - Nov, 2024

Experience

  • GV Research Platform (GVRP)
    • India
    • Research Services
    • 1 - 100 Employee
    • Associate Scientist-Toxicology
      • Jul 2023 - Present

      Nonclinical -Toxicologist: Nonclinical Toxicity! Product Safety Evaluation! Medical Device! Biocompatibility Testing. Rodent & Non-rodent Biocompatibility Studies. Regulatory toxicology, Non Clinical Biocompatibility Studies. Biocompatibility test planning, management, monitoring, reporting and toxicological data interpretation of systemic toxicity (acute & repeated), Irritation Tests, Sensitisation Tests, Implantation Tests and Pyrogen tests. In conclusion, these biocompatibility tests are essential for assessing the safety and efficacy of medical devices. They aid in regulatory compliance and protect human health throughout the device development process. Show less

  • Freyr Solutions
    • United States
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Senior Associate-Toxicology
      • Dec 2021 - Aug 2023

      Regulatory Toxicology: HBEL evaluations, PDE/ADE, OEL, ISO 10993, Extractables/leachables using PQRI, QSAR assessment, CTD 2.4 and 2.6 Health Based Exposure Levels: PDE Limit Reports: Software tools can help analyze data, perform calculations, and interpret results to determine the acceptable daily exposure levels for pharmaceutical substances. This involves considering factors like toxicity, potency, and specific target organs. OEL Assessment: Occupational exposure limits for hazardous substances in the workplace can be evaluated using software tools and data on toxicological properties and workplace exposure scenarios. This ensures worker safety and compliance with regulatory guidelines. Extractable and Leachable Studies: Available software can assist in characterizing the potential migration of substances from packaging or medical devices into pharmaceutical products. By comparing data to appropriate safety thresholds, potential risks can be assessed and mitigated. QSAR Assessment: Quantitative Structure-Activity Relationship analysis can be performed using software tools to predict the toxicity of chemicals based on their molecular structures. This helps in prioritizing testing and understanding potential risks. Writing Nonclinical Overview (CTD Module 2.4) and Nonclinical Written Summaries (CTD Module 2.6) are crucial components of a regulatory submission for Pharmaceutical products Biocompatibility Risk Assessment of a Medical Device using ISO 10993 standards is a comprehensive evaluation process to ensure the safety and compatibility of the device with human tissues and biological systems. ISO 10993 is an international standard that provides guidelines for assessing the biocompatibility of medical devices. Overall, conducting risk assessments using software tools facilitates the systematic evaluation of chemical safety, ensuring compliance with regulations and safeguarding the health of workers and consumers. Show less

  • Vivo Bio Tech Ltd.
    • India
    • Research Services
    • 200 - 300 Employee
    • Research Associate-Toxicology
      • Mar 2019 - Dec 2021

      Preclinical -Toxicologist: Preclinical Toxicity! Product Safety Evaluation! ADME and Efficacy ! Immunogenicity Rodent & Non-rodent Toxicity studies Regulatory toxicology, Non clinical toxicology studies and Immunogenicity studies for vaccines and biologicals Non clinical study planning, management, monitoring, reporting and toxicological data interpretation of acute, subchronic, chronic, carcinogenicity, genotoxicity. ADME and pharmacology efficiency studies In conclusion, these non-clinical studies are essential for assessing the safety and efficacy of pharmaceutical products, chemicals, vaccines, and biologicals. They aid in regulatory compliance and protect human health throughout the product development process. Show less

  • ClinChoice
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Trainee-Toxicology
      • Jun 2018 - Mar 2019

      Regulatory Toxicology: Human Based Exposure Limits! Hazard Identification! Risk assessment of pharmaceutical products, chemicals, ingredients and impurities! Toxicological review, preparation of reports of PDE/ADE, OEL Mongraphs for pharmaceuticals, impurities and leachable/extractables Hazard Identification: Hazard identification involves the systematic assessment of the potential adverse effects of pharmaceutical products, chemicals, ingredients, and impurities. This step identifies and characterizes the hazards associated with each substance, considering factors such as toxicity, genotoxicity, carcinogenicity, and sensitization. Risk Assessment: Risk assessment combines hazard identification with exposure assessment to determine the potential risks posed by pharmaceutical products, chemicals, ingredients, and impurities to human health. It evaluates the likelihood and severity of adverse effects resulting from exposure and considers factors like duration, frequency, and route of exposure Show less

Education

  • National Institute of Pharmaceutical Education and Research
    Regulatory Toxicology (Masters degree), Toxicology
    2016 - 2018
  • Vivekananda Group of Institutions
    Bachelor of Pharmacy - BPharm, Pharmacy
    2012 - 2016
  • Nagarjuna junior college
    Intermediate, Biology/Biological Sciences, General
    2010 - 2012

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