Title 7. PRE-CLINICAL EVALUATIONS.pdf ✅

PHARMD GURU Page 1 G) PRE-CLINICAL EVALUATIONS  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.  On an average, only one in 5,000 compounds which enter drug discovery to the stage of clinical development becomes an approved drug.  Each class of product may undergo different types of pre-clinical research. Drugs may undergo pharmacodynamic (PD), pharmacokinetic (PK) and toxicological testing.  This data allows researchers to estimate a safe starting dose of the drug for clinical trials in humans.  While performing pre-clinical studies, Good Laboratory Practices (GLPs) are followed.  Typically, both in-vitro and in-vivo tests are performed. Studies of a drug’s toxicities include which organs are targeted by the drug.  Three special types of toxicities are performed: they are carcinogenicity (tests for evaluating potential to cause cancer), mutagenecity (tests for evaluating mutagenic potential) and tetatogenecity (tests for evaluating potential damage to fetus during pregnancy of mother). ANIMAL TESTING:  Information collected from pre-clinical studies is vital for safe human testing.  Typically, animal testing involves at least two species. The choice of species is based on animals which will give best correlation to human trials.  Usually murine animals like mice/rats and canine animals like dogs are used for testing.  In addition, primates like monkeys or porcine animals like pigs may be used for pre- clinical testing. GENERAL PHARMACOLOGY