1. Safety pharmacology v
• Tier 2
• Ragini Anil Dani 1
• 2nd semester
• PJLEP ad
• Tier 2 Safety P’cological Studies
• * Also called as Supplemental
• pharmacological studies.
• D le
• * Used to access potential adverse
2. Renal studies in safety
pharmacology
• * 30-40% drugs invented can cause
• renal injury
• * Still the safety P’cological studies
• related to renal system in preclinical
• system is small
• Methods to assess drug effects on Renal
Functic J
• —
• * Itshould cover
3. In-Vivo Mammalian Models
• ssa
• Mice primates
• * Rats, Dogs, Pigs are commonly used feet oe
=a
• , a
• e500
• * Conscious, Freely moving animals L >
• * Analysis of urine and plasma are done.
• * Urinary bladder catherterization and
4. Ey
• Adhesive Patch
• b. Tubular Function
• nz
• * allows the identification of the
• : ; Color yellow
• functional status of particular Transparency
deat
• nephron segments H 87
• Specific Gravity 1,001-1.035 {adult-random ur
5. b. Tubular Function
• AA
• * allows the identification of the Color yw
• functional status of particular Tranarncy deat
• nephron segments 1H 97
• Specific Gravity 1,001-1.035 (adul-random ur
• * includes visual assessment of urine Protein,
Albumin negaive-race jn a concentra.
• (color, clarity), volume, specificgravity
specimen)
6. In Vitro Models
• The kidney is highly complex, composed of a
filter unit and a tubular segment, together
• containing over 20 different cell types.
• Nephrotoxicants cause injury by selectively
injuring specific cell types or by nonselectively
injuriny,
• multiple cell types within the kidney,
depending on their mechanism of action
• Assessment of the potential nephrotoxic
effects of pharmaceutical compounds on
