Project description
assignment question: You are part of a project team tasked with putting together the development plan for a new small molecule tyrosine kinase inhibitor (TKI) to be

used in the first instance in late stage prostatic cancer. You have asked the team member from the toxicology group to present their plan to see the product through

onto the market.
What would expect them to suggest as the studies they would propose doing and how they would schedule them relative to the clinical trial plan?

1)introduction. (to include: what is (TKI)? what is it used for? hoe they effect the cells ? how they work? toxicity? test modules “rats, dogs, primates”? how will

first into man studies “dose” will be carried out?? references: (ICH s9 anti-cancer toxicology guidelines)(GLP guidelines) for headings and ideas. search literature

for (TKI)

2)non-clinical evaluation:

A)safety pharmacology tests and studies ( test unwanted effects or pharmacodynamic characteristics on organ function and its potential relevance to humans will

this be determined? what are the safety pharmacology studies in vivo and in vitro? include species for each test , methodology and reason for study.)

b)acute toxicity studies. (include: purpose? recommended dosing method? the end points to be evaluated?)

c)repeat dose toxicity. (include: purpose? duration of exposure? maximum dosage for rodent and non-rodent? what to be analysed when doing repeat dose toxicity studies?

number and groups of animal in studies?recommendations for this (TKI) study? routes of administrations and why?
ref: (ICH S4 and M3 Guidelines)

3) A) phase one study. (recommendations? what should be included? parameters to calculate?dosage calculation? toxicokinetic studies? maximum tolerated dose?repeat dose

toxicity?data collection?)
ref:( ICH S9 Guidelines )

b) phase 2. ( recommendations of what to be carried out?clinical efficacy? safety? what to carry out before progressing to phase 3)

c) phase 3. (recommendations?reproductive studies? genetic toxicology? carcinogenicity ? immunotoxilogical studies? impurity evaluation? other studies?

(ICH S9 anti-cancer toxicology Guidelines) ****
(ICH S9 Guidelines) ****
(ICH S4 AND M3 Guidelines)
and others from instructions and from literature

please note: sessions will be attached for better understanding and answering of some of the headings given.

in answering the headings phase 1, 2 and 3. please use proof of principle (PoP) in clinical drug development for phase 1,2 and 3. (literature)


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