Pre-Clinical and Clinical Trials

Clinical trials allow the drug to be tested for safety by different ethnic population. In drug developmentpreclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools.

Market Analysyis : The global clinical trials market size was valued at USD 40.0 billion in 2016 and is expected to grow at a CAGR of 5.7% over the forecast period. Key drivers impacting the market growth are globalization of clinical trials, development of new treatments such as personalized medicine, augmenting evolution in technology, and boosting demand for CROs to conduct clinical trials. CROs diversified expertise as compared to pharmaceutical companies with respect to performing clinical trials in wide array In January 2015, Hospira submitted one of the biosimilar versions of Epogen (Epoetin Alfa) and the result of the review in the U.S. is anticipated from the FDA within a year.

  • Clinical trials on drugs used in respiratory disorders
  • Classification of various adverse drug reactions
  • Risk communication: Interface between pharmacovigilance, sales and marketing
  • Recent clinical trials on AIDS
  • Mechanism of adverse drug reactions
  • Pre-Clinical Testing
  • Scientific Models for Pre-Clinical and Clinical Trials
  • Designing of trials: pre-clinical studies
  • Bioassay and its types
  • Data collection and quality control
  • Alternative trials design and models
  • Multi center trials and monitoring
  • Regulatory authorities and ethics committee
  • Expected and un-expected drug reactions and its reporting

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