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TOXIC STUDIES
K V GOPINATH M Pharm PhD,CPhT
Tirumala Tirupati Devasthanams
TIRUPATI
e-mail:gopinath.karnam@gmail.com
Definitions
 Toxicity : Any toxic (adverse) effect that a chemical or physical
agent might produce within a living organism.
 Toxicology
Types of Toxic Studies
 Acute toxicity : It refers to those adverse effects occurring
following oral or dermal administration of a single dose of a
substance, or multiple doses given within 24 hours, or an inhalation
exposure of 4 hours.
 Sub acute Toxicity: It resembles acute toxicity except that the
exposure duration is greater, from several days to one month.
 Sub chronic toxicity: It is the toxic exposures repeated or spread
over an intermediate time range (1 – 3 months)
 Chronic Toxicity: It is the exposures (either repeated or
continuous) over a long (greater than 3 months) period of time.
SINGLE DOSE ACUTE TOXICITY
TESTING FOR PHARMACEUTICALS
INTRODUCTION
 Acute toxicity studies in animals are usually necessary for any
pharmaceutical intended for human use.
 It is useful in choosing doses for repeat-dose studies, providing
preliminary identification of target organs of toxicity, and,
occasionally, revealing delayed toxicity.
 Acute toxicity studies may also aid in the selection of starting doses
for Phase 1 human studies, and provide information relevant to acute
overdosing in humans.
DEFINITION
 Acute toxicity is the toxicity produced by a pharmaceutical when it is
administered in one or more doses during a period not exceeding 24
hours.
TESTING PROCEDURES
 The test compound should be administered to animals to identify
doses causing no adverse effect and doses causing major (life-
threatening) toxicity.
 The use of vehicle control groups should be considered
 Acute toxicity studies in animals should ordinarily be conducted
using two routes of drug administration: (1) The route intended for
human administration, and (2) intravenous administration, if feasible.
 Studies should be conducted in at least two mammalian species
(Rodents and non rodents)
CLASSIFICATION CRITERIA FOR
SUBSTANCES
Exposure Route Exposure Route 1
Category 1
Exposure Route
Category 2
Exposure Route
Category 3
Exposure Route
Category 4
Exposure Route
Category 5
Oral
(mg/kg)
5 50 300 2000 5000
Dermal
(mg/kg)
50 200 1000 2000
Gases
(PPM)
100 500 2500 5000
Vapours
Mg/l
0.5 2 10 20
Dusts &
Mists
0.05 0.5 1.0 5.0
OBSERVATION
 Animals should be observed for 14 days after pharmaceutical
administration. All mortalities, clinical signs, time of onset, duration,
should be recorded.
 Also reversibility of toxicity should be recorded.
 Gross necropsies should be performed on all animals, including those
sacrificed, moribund, found dead, or terminated at 14 days.
 Clinical pathology and histopathology should be monitored at an
early time and at termination (i.e., ideally, for maximum effect and
recovery).
 The toxicity studies should be designed to assess dose-response
relationships and pharmacokinetics to develop the lead compound.
CHRONIC TOXICITY STUDIES
 It is the ability of the substance or mixture of substances to cause
harmful effects over an extended period, usually upon repeated and
continuous exposure.
 The result of chronic toxicity study in animals should suggest signs
and symptoms of adverse reactions to look for in man.
PRINCIPLE OF TOXICITY STUDIES
 PRINCIPLE OF TOXICITY STUDIES
- Standard operating procedures (SOP’s) and NIH guidelines
should be thoroughly followed for these studies.
- It should be performed by well trained and qualified staff. -
- These should comply with norms of good laboratory
practices. - The test substances and systems should be properly
characterized and standardized.
 ANIMAL PROTECTION Studies should be designed so that the
maximum amount of information is obtained from the smallest
number of animals
 To avoid causing excessive pain or tissue damage in the animals,
pharmaceuticals with irritant or corrosive characteristics should not
be administered in concentrations that produce severe toxicity solely
from local effects.
Proposals For Clinical Study
Certain basic studies should be considered mandatory when
examining drug action in vivo
1. Make an assessment of drug exposure in the animal, preferably by
measurement of plasma drug concentrations at several time
points, and after several different doses.
2. Perform a measurement of the degree of plasma protein binding
of the drug, ex vivo if possible, and if not, then in vitro. This is vital
if comparisons are to be made of a drug action in more than one
species.
3. Obtain knowledge on the metabolism of the drug and determine
whether active metabolites could be influencing the results being
obtained.
Proposals For Clinical Study
4. Ensure that the dose schedules to be used are relevant to the way
that the drug will be used in humans to allow translational value to
the clinic.
5. Consider whether there is a temporal mismatch between the
exposure information being gained and the outcome measure being
investigated because this might give insight into the mechanism of
action of the compound under investigation.
6. Consider the determinants of target engagement whenever the
information above has been gathered.
Toxic studies

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Toxic studies

  • 1. TOXIC STUDIES K V GOPINATH M Pharm PhD,CPhT Tirumala Tirupati Devasthanams TIRUPATI e-mail:gopinath.karnam@gmail.com
  • 2. Definitions  Toxicity : Any toxic (adverse) effect that a chemical or physical agent might produce within a living organism.  Toxicology Types of Toxic Studies  Acute toxicity : It refers to those adverse effects occurring following oral or dermal administration of a single dose of a substance, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.  Sub acute Toxicity: It resembles acute toxicity except that the exposure duration is greater, from several days to one month.  Sub chronic toxicity: It is the toxic exposures repeated or spread over an intermediate time range (1 – 3 months)  Chronic Toxicity: It is the exposures (either repeated or continuous) over a long (greater than 3 months) period of time.
  • 3. SINGLE DOSE ACUTE TOXICITY TESTING FOR PHARMACEUTICALS INTRODUCTION  Acute toxicity studies in animals are usually necessary for any pharmaceutical intended for human use.  It is useful in choosing doses for repeat-dose studies, providing preliminary identification of target organs of toxicity, and, occasionally, revealing delayed toxicity.  Acute toxicity studies may also aid in the selection of starting doses for Phase 1 human studies, and provide information relevant to acute overdosing in humans. DEFINITION  Acute toxicity is the toxicity produced by a pharmaceutical when it is administered in one or more doses during a period not exceeding 24 hours.
  • 4. TESTING PROCEDURES  The test compound should be administered to animals to identify doses causing no adverse effect and doses causing major (life- threatening) toxicity.  The use of vehicle control groups should be considered  Acute toxicity studies in animals should ordinarily be conducted using two routes of drug administration: (1) The route intended for human administration, and (2) intravenous administration, if feasible.  Studies should be conducted in at least two mammalian species (Rodents and non rodents)
  • 5. CLASSIFICATION CRITERIA FOR SUBSTANCES Exposure Route Exposure Route 1 Category 1 Exposure Route Category 2 Exposure Route Category 3 Exposure Route Category 4 Exposure Route Category 5 Oral (mg/kg) 5 50 300 2000 5000 Dermal (mg/kg) 50 200 1000 2000 Gases (PPM) 100 500 2500 5000 Vapours Mg/l 0.5 2 10 20 Dusts & Mists 0.05 0.5 1.0 5.0
  • 6. OBSERVATION  Animals should be observed for 14 days after pharmaceutical administration. All mortalities, clinical signs, time of onset, duration, should be recorded.  Also reversibility of toxicity should be recorded.  Gross necropsies should be performed on all animals, including those sacrificed, moribund, found dead, or terminated at 14 days.  Clinical pathology and histopathology should be monitored at an early time and at termination (i.e., ideally, for maximum effect and recovery).  The toxicity studies should be designed to assess dose-response relationships and pharmacokinetics to develop the lead compound.
  • 7. CHRONIC TOXICITY STUDIES  It is the ability of the substance or mixture of substances to cause harmful effects over an extended period, usually upon repeated and continuous exposure.  The result of chronic toxicity study in animals should suggest signs and symptoms of adverse reactions to look for in man.
  • 8. PRINCIPLE OF TOXICITY STUDIES  PRINCIPLE OF TOXICITY STUDIES - Standard operating procedures (SOP’s) and NIH guidelines should be thoroughly followed for these studies. - It should be performed by well trained and qualified staff. - - These should comply with norms of good laboratory practices. - The test substances and systems should be properly characterized and standardized.  ANIMAL PROTECTION Studies should be designed so that the maximum amount of information is obtained from the smallest number of animals  To avoid causing excessive pain or tissue damage in the animals, pharmaceuticals with irritant or corrosive characteristics should not be administered in concentrations that produce severe toxicity solely from local effects.
  • 9. Proposals For Clinical Study Certain basic studies should be considered mandatory when examining drug action in vivo 1. Make an assessment of drug exposure in the animal, preferably by measurement of plasma drug concentrations at several time points, and after several different doses. 2. Perform a measurement of the degree of plasma protein binding of the drug, ex vivo if possible, and if not, then in vitro. This is vital if comparisons are to be made of a drug action in more than one species. 3. Obtain knowledge on the metabolism of the drug and determine whether active metabolites could be influencing the results being obtained.
  • 10. Proposals For Clinical Study 4. Ensure that the dose schedules to be used are relevant to the way that the drug will be used in humans to allow translational value to the clinic. 5. Consider whether there is a temporal mismatch between the exposure information being gained and the outcome measure being investigated because this might give insight into the mechanism of action of the compound under investigation. 6. Consider the determinants of target engagement whenever the information above has been gathered.