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Questions and Answers
What type of studies is the guinea pig particularly useful for in immunology?
What type of studies is the guinea pig particularly useful for in immunology?
Which organ preparation is noted as particularly sensitive for screening spasmodic compounds?
Which organ preparation is noted as particularly sensitive for screening spasmodic compounds?
What is the primary use of rabbits in experimental studies?
What is the primary use of rabbits in experimental studies?
Which type of animal is noted for being widely used in IVF research?
Which type of animal is noted for being widely used in IVF research?
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What is the main characteristic of nude mice in experimental research?
What is the main characteristic of nude mice in experimental research?
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For which of the following purposes are albino mice primarily used?
For which of the following purposes are albino mice primarily used?
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Which of the following is NOT a use for isolated organs or tissues of rabbits?
Which of the following is NOT a use for isolated organs or tissues of rabbits?
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Which compound is NOT mentioned as being tested using isolated guinea pig tissues?
Which compound is NOT mentioned as being tested using isolated guinea pig tissues?
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What is the primary goal of rehabilitation in animal testing?
What is the primary goal of rehabilitation in animal testing?
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Which of the following is NOT a component required in the Investigational New Drug (IND) application?
Which of the following is NOT a component required in the Investigational New Drug (IND) application?
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How many healthy volunteers typically participate in Phase 1 clinical trials?
How many healthy volunteers typically participate in Phase 1 clinical trials?
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What is the main purpose of preclinical research?
What is the main purpose of preclinical research?
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What must researchers develop before beginning a clinical trial?
What must researchers develop before beginning a clinical trial?
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During which Clinical Research Phase is the main focus on safety and dosage?
During which Clinical Research Phase is the main focus on safety and dosage?
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What is the significance of animal study data in the IND application?
What is the significance of animal study data in the IND application?
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Which statement best reflects the role of researchers in designing clinical trials?
Which statement best reflects the role of researchers in designing clinical trials?
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What is the main purpose of Phase 3 studies?
What is the main purpose of Phase 3 studies?
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What happens during Phase 4 trials?
What happens during Phase 4 trials?
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What is included in a New Drug Application (NDA)?
What is included in a New Drug Application (NDA)?
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Which of the following is NOT a component of the NDA review process?
Which of the following is NOT a component of the NDA review process?
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What must a drug developer include in the NDA regarding safety updates?
What must a drug developer include in the NDA regarding safety updates?
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How long does the FDA review team typically take to make a decision on an NDA?
How long does the FDA review team typically take to make a decision on an NDA?
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What is the role of FDA inspectors during the NDA review process?
What is the role of FDA inspectors during the NDA review process?
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What happens if the NDA is incomplete upon review by the FDA?
What happens if the NDA is incomplete upon review by the FDA?
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What is the primary purpose of bio-equivalence studies conducted by generic drug manufacturers?
What is the primary purpose of bio-equivalence studies conducted by generic drug manufacturers?
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Which of the following is NOT a stage of general anesthesia?
Which of the following is NOT a stage of general anesthesia?
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What characterizes Stage 2 of anesthesia?
What characterizes Stage 2 of anesthesia?
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What is the main function of Midazolam in patient preparation before induction?
What is the main function of Midazolam in patient preparation before induction?
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Which inhaled anesthetic has abuse potential and no metabolism?
Which inhaled anesthetic has abuse potential and no metabolism?
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What is the consequence of using Chlorofluorocarbons as an inhaled anesthetic?
What is the consequence of using Chlorofluorocarbons as an inhaled anesthetic?
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Which intravenous anesthetic is known to potentially cause type B acidosis?
Which intravenous anesthetic is known to potentially cause type B acidosis?
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What is the primary goal of Stage 3 of anesthesia?
What is the primary goal of Stage 3 of anesthesia?
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What significance did Thomas Hunt Morgan's research on fruit flies hold?
What significance did Thomas Hunt Morgan's research on fruit flies hold?
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Which of the following diseases can researchers study using fruit flies?
Which of the following diseases can researchers study using fruit flies?
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What is Trabectedin (Yondelis) derived from?
What is Trabectedin (Yondelis) derived from?
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Which compound type from starfish shows potential for pharmaceutical applications?
Which compound type from starfish shows potential for pharmaceutical applications?
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How have toxins from tunicates been utilized in medicine?
How have toxins from tunicates been utilized in medicine?
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What traditional medicinal use is associated with starfish extracts?
What traditional medicinal use is associated with starfish extracts?
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What aspect of Alzheimer's disease has recent research focused on with fruit flies?
What aspect of Alzheimer's disease has recent research focused on with fruit flies?
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What is a significant benefit of using starfish-derived compounds in cancer treatment?
What is a significant benefit of using starfish-derived compounds in cancer treatment?
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Study Notes
Guinea Pig
- Utilized in immunology for delayed hypersensitivity studies with antigens like egg albumin and horse serum.
- Effective for local anesthetic studies and bioassay of digitalis; sensitive cochlea aids in hearing experiments and oxygen consumption studies.
- Requires exogenous vitamin C, making it a model for studying vitamin C metabolism.
- Serves as an appropriate host for Mycobacterium in tuberculosis research.
- Isolated organ preparations, such as lungs and intestines, contributed to early drug discoveries for stomach ulcers and beta-blockers.
- Terminal ileum is highly sensitive for assessing spasmodic and antispasmodic compounds, histamine detection and assay.
Mouse (Mus musculus)
- Albino mice are the smallest laboratory animals, bred uniformly for experiments.
- Commonly used in acute toxicity studies and in testing insulin, analgesics, and chemotherapeutic agents.
- Particularly significant in genetics, cancer research, and teratogenicity testing.
- Nude mice, lacking a thymus gland, are valuable for studying tissue immunity and transplantation.
Rabbits
- Primarily employed in pyrogen testing of intravenous fluids and studies of miotics and mydriatics.
- Used in research involving insulin, antidiabetic drugs, muscle relaxants like curare, and sex hormones.
- Isolated tissues from the heart, jejunum, and ileum are routinely used for drug testing.
Hamster
- Widely utilized in research fields including oncology, immunology, physiology, and particularly IVF (In-Vitro Fertilization) research.
Refinement
- Involves modifications of procedures to minimize pain and trauma in animal testing, emphasizing suitable and effective equipment.
Rehabilitation
- Focuses on treatments facilitating recovery from injury or illness, aiming to return animals to normal conditions.
Clinical Research
- Connects preclinical research with human studies; emphasizes the need for understanding drug interactions with the human body.
- Involves Investigational New Drug (IND) Process, which includes submitting an IND application to the FDA before clinical trials.
Designing Clinical Trials
- Clinical trials are designed around specific research questions; protocols outline the study plan.
- Researchers analyze previous data to establish research objectives and questions prior to trial initiation.
Investigational New Drug Process
- Sponsors must submit an IND application containing animal study data, manufacturing information, clinical protocols, and prior human research data.
Clinical Research Phase Studies
- Phase 1: Involves 20 to 100 healthy volunteers focusing on safety and dosage.
- Phase 3: Trials with several thousand participants assess safety and efficacy.
- Phase 4: Conducted post-marketing to monitor safety.
FDA Drug Review
- Applications to market drugs require the submission of comprehensive safety and effectiveness data.
- Review team evaluates the application's completeness and conducts inspections at clinical study sites.
New Drug Application (NDA)
- An NDA presents the comprehensive data supporting a drug’s safety and efficacy, including clinical results and required labeling.
Anesthesia
- Anesthesia: Loss of response to pain; includes analgesia for non-pain relief.
- General anesthesia induces controlled unconsciousness during surgery.
Inhaled Anesthetics
- Nitrous Oxide: First general anesthetic; no metabolism but abuse potential.
- Chlorofluorocarbons: Can cause respiratory irritation; lower irritation risks with Sevoflurane.
Intravenous Anesthetics
- Includes medications like Propofol, barbiturates (Thiopental, Methohexital), and Ketamine, among others.
Patient Preparation for Induction
- Techniques to calm and sedate patients involve Midazolam, Dexmedetomidine, and Atropine.
Stages of Anesthesia
- Stage 1: Induction to loss of consciousness; includes analgesia and euphoria.
- Stage 2: Hyperexcitable phase where the body temporarily loses normal autonomic control.
- Stage 3: Desired state of unconsciousness, stable autonomics, and minimal eye movement.
Fruit Flies in Research
- Utilized for genetic studies; recognized for contributions to understanding development and diseases including Parkinson's and Alzheimer's.
- Essential in drug development for treating pathogens causing a variety of infections.
Tunicates (Sea Squirts)
- Invertebrate chordates with biologically active compounds; potential applications in cancer treatment with drugs like Trabectedin (Yondelis).
Starfish
- Source of bioactive compounds with applications in cancer, anti-inflammatory, and antimicrobial therapies; used in traditional medicine for digestive health.
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