Principles of Non-clinical trials Flashcards
Non-clinical testing of drugs
A. Apply to in-vivo or in-vitro experiments in which the test article
B. Include studies utilizing human beings
C. Are concerned only with studies in animals prior to clinical drug trials
D. AOTA except C
A
Acute toxicity studies based on ICH Technical requirements:
A. Can be derived from single dose toxicity studies from 2 mammalian species using clinical route in humans and 14 days of observation of animals even if lethality is not the intended end point
B. Can be attained from appropriately conducted dose-escalation studies/ short duration dose ranging studies that define max tolerated dose in general toxicity test species
C. Should provide info to predict the consequences of human overdose situations and should be available to support Phase II human clinical trials for which patient population are at higher risk of overdosing
D. Any of the above
D
The general principles of the Guidelines for Non-Clinical Safety Studies include
A. Characterization of toxic effects with respect to target organ
B. Establishment of safety pharmacology by toxicity studies, assessment of vital functions
C. Case by case approach to assessment of phototoxicity, immunotoxicity, juvenile animal toxicity, and abuse liability
D. AOTA
D
The guidance on the Non-clinical safety studies for the conduct of human clinical trials required by the 2009 ICH of technical requirements for registration of pharmaceuticals for human use include:
A. As its specific objective, to reduce the use of animals in accordance with 3R (reduce, replace, re) principles
B. To use new in vitro alternative methods for safety evaluation
C. As its scope assessment of carcinogenicity potential for drugs that have special cause for concern
D. A and B
D
True of Acute Toxicity Non-clinical Studies:
A. 2 mammalian species using both clinical and parenteral routes; 1 dose; observed for 14
days
B. Lethality is intended end point.
C. Cannot be obtained from dose-escalation studies
D. Cannot be used to predict consequences of human overdose
A
The International Committee on Harmonization (ICH) Tripartite Guidelines on Non-clinical Safety Studies for the Conduct of Human clinical Trials state the ff. except:
A. Any substance or combination of substances which has a therapeutic, prophylactic, or diagnostic purpose, or is intended to modify physiological functions and presented in a dosage form suitable for administration in humans.
B. To promote safe, ethical development and availability of new pharmaceuticals
C. For situations encountered during the conventional development of pharmaceuticals
D. For biotechnology-derived products pharmaceuticals for life-threatening or serious
diseases without effective current therapy.
D
The ethical and technical standards on the proper care and use of laboratory animal require that
a) . procedures involving animal should be designed and performed to advance knowledge even if there is no relevance to human or animal health
b) . the animal selected for a procedure should be the appropriate species and quality using the maximum number of animal to obtain valid results
c) . sedation, analgesia and anesthesia should be used when procedures with animals may cause more than momentary or slight pain´
d) . all of the above
e) . a & c only
C
Short term toxicity in animal
a) . has a duration of 21 days (subacute) or 90days (sub-chronic)
b) . can determine if cumulative toxicity r tolerance occurs and the target organs involved with continued exposure of the animal to the test substance
c) . can determine the dose with NO observed effect and maximum tolerated dose in animal
d) . all of the above
e) .a & c only
D
The following statements are true
a) if a drug is to be administered to human for 6 months or more a phase 1 clinical trial may be conducted if 2 species of animal have completed 3 months of testing with favorable results
b) . acute toxicity testing in animal can give information regarding the chronicity index of the drug
c) . pharmacologic screening utilize biologic assay at molecular,cellular,organ system and whole animal levels to define the activity and selectivity of the drug
d) . all of the above
e) .a & c only
E
