Toxicity Flashcards
What are the clinical signs if toxicity?
Repiratory- dyspnea, abnormal breathing,gasping,cynosis – limbs not getting enough oxygen, Motor activity – loss of reflexes,ataxia,tremors,ocular signs,GTT signals ,sexual dysfunction.
Quantifying toxicity – What is ED50?
– effective dose- the amount of drug that causes 50% of maximum effect for any measured biological effect of interest.
What is LD50?
Lethal dose – The amount of drug that kills 50% of the a test sample
What is NOAEL?
The highest concentration that does not cause a toxic response -
when noael is determined, it must be converted to human equivalent dose
What is HED?
adjusting for anticipated exposure in humans and interspecies
difference in affinity+ potency. A 10 fold – safety factors should be applied
What is the HED calculation?
Human equivalent dose- Noel x animal km /human km
What is Loel?
The lowest concentration that produces a toxic effect.
What does the IND contain?
Investigational new drug application – this is an evaluation
of what has been discovered/ tests performed and the plan for future grading –
regarding potential new drug.
What are the 4 pannels for review?
1) the medication panel – looks at the
manufacturing and the quality assurance for example 2) chemistry panel – chem of drug - stability etc.3) The pharmacology toxicology panel look at preclinical. 4)The statistical apnnels – look at the accuracy of the protocol to make sure the plan meets the requirements for hypothesis – whether the sample size is big enough.A safety review is conducted which indicstes the data is afe of not
What is the NDA
New drug Applicatio NDA – final piece of evidence – That is
submitted before the drug is brought- to the market
What are the modules for CTD?
Module 1 – regional administration information,
Module 2 – Quality , Module- 3 – Quality, Module 4- clinical study,
