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
A)safety pharmacology tests and studies ( test unwanted effects or pharmacodynamic characteristics on organ function and its potential relevance to humans ..how 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
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)
PLACE THIS ORDER OR A SIMILAR ORDER WITH US TODAY AND GET AN AMAZING DISCOUNT ?
Our Service Charter
Excellent Quality / 100% Plagiarism-FreeWe employ a number of measures to ensure top quality essays. The papers go through a system of quality control prior to delivery. We run plagiarism checks on each paper to ensure that they will be 100% plagiarism-free. So, only clean copies hit customers’ emails. We also never resell the papers completed by our writers. So, once it is checked using a plagiarism checker, the paper will be unique. Speaking of the academic writing standards, we will stick to the assignment brief given by the customer and assign the perfect writer. By saying “the perfect writer” we mean the one having an academic degree in the customer’s study field and positive feedback from other customers.
Free RevisionsWe keep the quality bar of all papers high. But in case you need some extra brilliance to the paper, here’s what to do. First of all, you can choose a top writer. It means that we will assign an expert with a degree in your subject. And secondly, you can rely on our editing services. Our editors will revise your papers, checking whether or not they comply with high standards of academic writing. In addition, editing entails adjusting content if it’s off the topic, adding more sources, refining the language style, and making sure the referencing style is followed.
Confidentiality / 100% No DisclosureWe make sure that clients’ personal data remains confidential and is not exploited for any purposes beyond those related to our services. We only ask you to provide us with the information that is required to produce the paper according to your writing needs. Please note that the payment info is protected as well. Feel free to refer to the support team for more information about our payment methods. The fact that you used our service is kept secret due to the advanced security standards. So, you can be sure that no one will find out that you got a paper from our writing service.
Money Back GuaranteeIf the writer doesn’t address all the questions on your assignment brief or the delivered paper appears to be off the topic, you can ask for a refund. Or, if it is applicable, you can opt in for free revision within 14-30 days, depending on your paper’s length. The revision or refund request should be sent within 14 days after delivery. The customer gets 100% money-back in case they haven't downloaded the paper. All approved refunds will be returned to the customer’s credit card or Bonus Balance in a form of store credit. Take a note that we will send an extra compensation if the customers goes with a store credit.
24/7 Customer SupportWe have a support team working 24/7 ready to give your issue concerning the order their immediate attention. If you have any questions about the ordering process, communication with the writer, payment options, feel free to join live chat. Be sure to get a fast response. They can also give you the exact price quote, taking into account the timing, desired academic level of the paper, and the number of pages.