Safety Pharmacology Studies | Types of Safety Pharmacology Studies | Tier-2 |

Safety Pharmacology Studies | Types of Safety Pharmacology Studies | Tier-2 | Renal & Gastro System
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Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. •
It identifies the “potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above”.
AIM : • To characterize the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug’s adverse effects using continuously evolving methodology.
The core battery SP studies, performed according to GLP standards as per ICH guidelines, involves the investigation of major vital organisms.
SAFETY PHARMACOLOGY STUDIES
TIER 1 - CORE BATTERY • CVS • CNS • Respiratory
TIER 2 - SUPPLEMENTARY STUDIES • Renal • Gi system • Other
Renal studies in safety pharmacology •
The kidney is a complex excretory organ Playing role in
Fluid and electrolyte balance
Control of blood pressure
Removal of waste products
Drug disposition
Endocrine function

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Unit 1 ke topics