Lwcture 18 - In Vivo Flashcards
(37 cards)
What is a pro of using animal models in drug development?
Whole Organism Complexity: Animal models provide an intact living system to evaluate the pharmacokinetics, pharmacodynamics, efficacy, and toxicity of drug candidates.
In vitro or in silico models cannot fully mimic these aspects.
What is meant by ‘Predictive Value’ in the context of animal models?
Historically, animal studies have helped predict human responses, including potential adverse effects.
This guides safer progression into clinical trials.
What is a key ethical concern related to animal models?
Animal welfare issues lead to social and regulatory pressure to reduce or replace animal use.
Ethical considerations are increasingly influencing research practices.
What does the 3Rs Principle in animal research stand for?
Reduce, Replace, Refine.
Aims to minimize the number of animals used and improve their welfare.
What is the purpose of Phase 1 clinical trials?
Safety and dosage determination.
Involves a small group of healthy or diseased participants.
Fill in the blank: The _______ framework (Population, Intervention, Control, Outcome, Time) helps define the objective of an in vivo study clearly.
PICO(T)
What is the main focus of Phase 3 clinical trials?
Confirm therapeutic effect and safety.
Involves large, diverse patient groups and utilizes randomized, controlled designs.
What are the PREPARE Guidelines?
Comprehensive planning covering study formulation, execution, and animal welfare.
Includes husbandry, housing, and handling.
True or False: Phase 4 clinical trials focus on preliminary efficacy and dosing.
False.
Phase 4 focuses on long-term safety, effectiveness, and rare events.
What is a limitation of animal models in drug development?
Species Differences: Animal physiology and metabolism can differ from humans, leading to false positives or negatives.
This limits translational reliability.
What is the significance of control groups and randomization in an in vivo study?
Minimize bias.
Proper controls and random assignment are crucial for study validity.
What should be considered when selecting species for an in vivo study?
Ethical, biological, and practical aspects.
Relevant species to the human disease or biological system should be chosen.
What is the focus of Phase 2 clinical trials?
Therapeutic exploratory: Safety, preliminary efficacy, dosing.
Involves patients with the target disease.
What is a characteristic of Phase 0 clinical trials?
Early microdose studies to check pharmacokinetics/pharmacodynamics.
Usually involves a small number of participants, sometimes healthy.
What does ‘blinding’ refer to in the context of clinical trials?
Preventing observer bias.
Blinding is done when possible to ensure unbiased results.
What is the outcome focus of Phase 4 clinical trials?
Long-term safety, effectiveness, rare events.
These trials occur after the drug is on the market.
What is a consequence of recent regulatory changes regarding animal testing?
Calls for phasing out animal testing push development of alternatives.
This reflects a growing emphasis on ethical considerations.
What is the purpose of Phase 0 in clinical studies?
Early microdose studies to check PK/PD
PK stands for pharmacokinetics, and PD stands for pharmacodynamics.
What type of participants are involved in Phase 0 studies?
Small number, sometimes healthy
What are the study design characteristics of Phase 0?
Exploratory, low dose, sometimes first-in-human
What is the outcome focus of Phase 0?
Preliminary pharmacokinetics/dynamics
What is the main purpose of Phase 1 in clinical studies?
Safety and dosage
What type of participants are involved in Phase 1 studies?
Small group (healthy or diseased)
What are the study design characteristics of Phase 1?
Dose escalation, open-label, no controls
