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Biostatistics and Biological Standardization of Drugs, Code 306

Aim of the Course

To know about the newly introduced science of Safety Pharmacology or Preclinical Testing as an essential step in the process of drug development and post-marketing surveillance. Understanding of the indispensible need to test Investigational New Drug (IND) Safety before entering clinical trials is discussed. Focus is made on Batteries of testing CVS, CNS and Respiratory pharmacological safety. Relation of such tests to monitoring adverse reactions of drugs in post-marketing surveillance is indicated. In practical sessions, students are trained to interpret results of published studies for IND as well as marketed drugs. Students also practice to see how such safety concerns, if any, are presented for patients and health professionals in Drug Information Leaflets during practical sessions. Knowledge of basic concepts of medical biostatistics is covered including its usage in the aforementioned tests.

Course Contents

  • Basic biostatistics
  • Introduction to screening and bioassay of drugs
  • Screening and bioassay of ANS acting drugs
  • Screening and bioassay of CNS acting drugs
  • Screening and bioassay of hormones
  • Screening and bioassay of histamine,
  • neuromuscular blockers and antihistaminics
  • Biological evaluation of other drugs

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