NPP 2 Flashcards
What is psycho/neuro-pharmacology?
The study of the effects of drugs on the nervous system and behavior.
This includes the history and development of psychotropic medications.
What are the major classes of psychotropic drugs?
- Antipsychotics
- Benzodiazepines (BZDs)
- Antimuscarinics
- Stimulants
- Hypnotics
These classes address various mental health issues and disorders.
What was the significance of chloral hydrate?
It was a sedative/hypnotic introduced in 1832.
Chloral hydrate marked the beginning of modern psychotropic drug development.
What discovery is attributed to John Cade in 1949?
The introduction of lithium as a treatment for bipolar disorder.
Cade’s work was pivotal in the development of mood stabilizers.
What was the first antidepressant introduced in 1957?
Monoamine oxidase inhibitors (MAOIs).
Iproniazid, a MAOI, was noted for causing elation in patients.
What is the Biogenic Amine Hypothesis of Depression?
A theory suggesting that depression is linked to a deficiency in biogenic amines, particularly serotonin and norepinephrine.
This hypothesis has influenced antidepressant development.
What regulatory changes were prompted by the thalidomide scandal?
The Medicines Act of 1968 was introduced to ensure drug safety and efficacy.
This act was a response to the teratogenic effects of thalidomide.
What is the role of the Medicines and Healthcare-products Regulatory Agency (MHRA)?
To advise UK ministers and regulate the safety and efficacy of medicines.
The MHRA is responsible for the licensing of drugs in the UK.
Fill in the blank: The first psychotropics were derived from _______.
[plant/fungal sources].
Who developed the first phenothiazines?
William Perkin in 1856.
Phenothiazines were originally developed as dyes before being used as antipsychotics.
True or False: The introduction of chlorpromazine was based on the science of neurotransmission.
True.
Chlorpromazine’s development was influenced by advances in understanding neurotransmission.
What was the significance of the 1968 Medicines Act?
It established a legal framework for drug licensing to ensure safety and efficacy.
This act was particularly important after the thalidomide tragedy.
What are the phases of drug development?
- Phase 1: Initial assessment of drug safety
- Phase 2: Efficacy and side effects in patients
- Phase 3: Larger trials for efficacy and safety
- Phase 4: Post-marketing surveillance
Each phase is critical for determining a drug’s safety and efficacy.
What major issue did thalidomide cause?
It led to severe teratogenic effects, including phocomelia.
Phocomelia is characterized by the failure of long bone development.
Who was Nathan Kline?
A psychiatrist noted for his work with iproniazid, the first MAOI.
Kline’s research highlighted the mood-enhancing effects of the drug.
What is the primary concern in drug regulation?
To ensure a positive risk-benefit appraisal for public safety.
This involves evaluating the safety and efficacy of drugs before approval.
What is the significance of the term ‘serendipity’ in drug discovery?
It refers to the unexpected discovery of drugs with therapeutic effects.
Many psychotropic drugs were discovered through serendipitous observations.
What is the role of marketing authorization holders (MAHs)?
They are manufacturers granted a license to promote drugs whose safety and efficacy have been demonstrated.
MAHs play a crucial role in the drug approval process.
What is the initial step in drug development?
Identification of molecule/s against specific biological target (‘candidate drug’)
What does the initial assessment in drug development include?
Theoretical efficacy, pharmacokinetics, toxicity, and safety
What is assessed in the preclinical phase of drug development?
Potential to cause serious harms and pharmacodynamics/kinetics
What is involved in Phase 1 clinical trials?
Tolerability/safety and repeat-dose pharmacokinetics in healthy volunteers
What is the sample size for Phase 2 clinical trials?
100 to 300 patients with the target disorder
What is the sample size for Phase 3 clinical trials?
300 to 3000 patients
