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SUBJECT
TOPIC
ANSARI AASHIF RAZA
(IInd semester , M.PHARM)
DEPARTMENT OF PHARMACOLOGY
Toxicokinetics is defined as the generation of pharmacokinetics data to
design, conduct & Interpretation drug safety evaluation studies.In
preclinical drug safety evaluation or toxicological studies, a minimum of
two animal species are employed, as per regulation of the FDA.
1. Rodents
e.g:-Rats, Mice.
2. Non-rodents
e.g:-Dog
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 2
1. Safety assessment:
Generally, the safety of a molecule can be performed in in-vivo systems.
This step is not included in the guidelines but it is very useful for the
researchers to assess the systemic exposure. This safety study is an integral part
of the CNS, CVS, and respiratory assessments.
2. Single dose and rising dose studies :
Studies performed in the very early stage of drug development before a
bioanalytical method. These studies are usually performed in rodents.Plasma
samples are taken and stored for later analysis
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 3
3. Repeated-dose toxicity studies :
To give support for phase 1 studies this study is carried out for four
weeks in both rodents as well as non-rodents. Help to support dose selection
for subsequent studies. Performing further repeated dose studies in both rodents
and non-rodents up to 6-12 months enables estimation of the drug and its
metabolite kinetic parameter assessment as well as long-term clinical exposure
assessment.
4. Genotoxicity studies :
Two in vitro studies and one in vivo study are essential to support the
development of drug. In vivo investigations usually use a rodent micronucleus
(bone marrow or peripheral erythrocytes) test or chromosome aberration (bone
marrow cells) test.
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 4
5. Reproduction toxicity studies :
Reproduction toxicity measurements are taken in studies of fertility (rat),
embryo-fetal development (rat and rabbit), and pre-or post-natal development
(rat).
6. Studies of fertility:
Assessment of fertility toxicity is very important because most of the drugs used in
fertility conditions have to strengthen at that time. Usually, this can be done in rats.
7. In pregnant and lactating animals:
There is a regulatory expectation for toxicokinetic data in pregnant animals,
although no specific guidance is given. Toxicokinetics may involve exposure
assessment of dams, embryos, foetuses, or newborns on specified days. Secretion
in milk may be assessed to define its role in the exposure of newborns. In some
situations, additional studies may be necessary or appropriate in order to study
embryo/foetal transfer and secretion in milk.
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 5
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 6
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 7
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 8
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 9
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 10
1. Important in drug development stages especially in the preclinical stage.
2. TK evaluation is useful for setting safe dose levels in clinical phases.
3. TK evaluation is useful in the selection of dose, dosing form, alternative dosing route, and
evaluation of toxicological mechanism, and also used for setting safe dose levels in clinical
phases.
4. TK studies are also used to reduce the animal number.
5. TK evaluation is very important in the drug development phase from both regulatory and
scientific perspectives.
6. TK data are practically used for the purpose of drug discovery such as lead-optimization
and candidate-selection.
7. Toxicokinetic data is important to know the toxic response to drug exposure obtained in
drug development stages.
8. It is used to set safe doses for clinical use of new drugs.
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 11
 Screening of anti-cancer drugs.
 Cell-based bioassays.
 To determine the cytotoxicity.
 In vitro screening of several drugs.
 Production of anti viral vaccines
 Cancer research, which require the study of uncontrolled cell division in culture.
 Cell fusion technique.
 Genetic manipulation.
 Gene therapy.
 Recombinant DNA therapy.
 Biotechnology.
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 12
TSM unit 5 Toxicokinetics seminar by  Ansari Aashif Raza.pptx

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TSM unit 5 Toxicokinetics seminar by Ansari Aashif Raza.pptx

  • 1. SUBJECT TOPIC ANSARI AASHIF RAZA (IInd semester , M.PHARM) DEPARTMENT OF PHARMACOLOGY
  • 2. Toxicokinetics is defined as the generation of pharmacokinetics data to design, conduct & Interpretation drug safety evaluation studies.In preclinical drug safety evaluation or toxicological studies, a minimum of two animal species are employed, as per regulation of the FDA. 1. Rodents e.g:-Rats, Mice. 2. Non-rodents e.g:-Dog ANSARI AASHIF RAZA {M PHARM 1 YEAR} 2
  • 3. 1. Safety assessment: Generally, the safety of a molecule can be performed in in-vivo systems. This step is not included in the guidelines but it is very useful for the researchers to assess the systemic exposure. This safety study is an integral part of the CNS, CVS, and respiratory assessments. 2. Single dose and rising dose studies : Studies performed in the very early stage of drug development before a bioanalytical method. These studies are usually performed in rodents.Plasma samples are taken and stored for later analysis ANSARI AASHIF RAZA {M PHARM 1 YEAR} 3
  • 4. 3. Repeated-dose toxicity studies : To give support for phase 1 studies this study is carried out for four weeks in both rodents as well as non-rodents. Help to support dose selection for subsequent studies. Performing further repeated dose studies in both rodents and non-rodents up to 6-12 months enables estimation of the drug and its metabolite kinetic parameter assessment as well as long-term clinical exposure assessment. 4. Genotoxicity studies : Two in vitro studies and one in vivo study are essential to support the development of drug. In vivo investigations usually use a rodent micronucleus (bone marrow or peripheral erythrocytes) test or chromosome aberration (bone marrow cells) test. ANSARI AASHIF RAZA {M PHARM 1 YEAR} 4
  • 5. 5. Reproduction toxicity studies : Reproduction toxicity measurements are taken in studies of fertility (rat), embryo-fetal development (rat and rabbit), and pre-or post-natal development (rat). 6. Studies of fertility: Assessment of fertility toxicity is very important because most of the drugs used in fertility conditions have to strengthen at that time. Usually, this can be done in rats. 7. In pregnant and lactating animals: There is a regulatory expectation for toxicokinetic data in pregnant animals, although no specific guidance is given. Toxicokinetics may involve exposure assessment of dams, embryos, foetuses, or newborns on specified days. Secretion in milk may be assessed to define its role in the exposure of newborns. In some situations, additional studies may be necessary or appropriate in order to study embryo/foetal transfer and secretion in milk. ANSARI AASHIF RAZA {M PHARM 1 YEAR} 5
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  • 11. 1. Important in drug development stages especially in the preclinical stage. 2. TK evaluation is useful for setting safe dose levels in clinical phases. 3. TK evaluation is useful in the selection of dose, dosing form, alternative dosing route, and evaluation of toxicological mechanism, and also used for setting safe dose levels in clinical phases. 4. TK studies are also used to reduce the animal number. 5. TK evaluation is very important in the drug development phase from both regulatory and scientific perspectives. 6. TK data are practically used for the purpose of drug discovery such as lead-optimization and candidate-selection. 7. Toxicokinetic data is important to know the toxic response to drug exposure obtained in drug development stages. 8. It is used to set safe doses for clinical use of new drugs. ANSARI AASHIF RAZA {M PHARM 1 YEAR} 11
  • 12.  Screening of anti-cancer drugs.  Cell-based bioassays.  To determine the cytotoxicity.  In vitro screening of several drugs.  Production of anti viral vaccines  Cancer research, which require the study of uncontrolled cell division in culture.  Cell fusion technique.  Genetic manipulation.  Gene therapy.  Recombinant DNA therapy.  Biotechnology. ANSARI AASHIF RAZA {M PHARM 1 YEAR} 12