General Pharmacology Flashcards
1.
Clinical trial phase 1
Objective: Focuses on assessing the safety of a drug. The trial seeks to find the drug’s most appropriate dosage and identify side effects.
Participants: Usually involves 20-100 healthy volunteers, though sometimes patients with the disease are used.
Outcome: Determines whether the drug is safe enough to proceed to further testing.
Clinical trial phase 2
Objective: Tests the efficacy of the drug and further evaluates its safety.
Participants: Larger groups (100-300) of patients who have the condition the drug is designed to treat.
Outcome: Aims to obtain preliminary data on whether the drug works in people who have a certain condition or disease. This phase also continues safety assessments.
Clinical trial phase 3
Objective: Confirms the drug’s effectiveness, monitors side effects, compares it to commonly used treatments, and collects information that will allow the drug or treatment to be used safely.
Participants: Large groups of people (1,000-3,000), providing a more thorough understanding of the drug’s effectiveness and the incidence of side effects.
Outcome: These studies provide the data necessary for the drug approval process and to include labeling information.
Clinical trial phase 4
Objective: Conducted after the drug has been approved for consumer sale. These trials gather additional information on the drug’s effect in various populations and any side effects associated with long-term use.
Participants: Larger and more varied patient populations.
Outcome: Further refines the drug’s usage and monitors long-term effectiveness and impact.
SUSMP schedule 1?
Schedule 1 of the SUSMP is not currently in use. It’s a category that is reserved for future use if needed for substances that don’t fit into the existing schedule definitions.
SUSMP schedule 2?
Pharmacy Medicines: These are substances and preparations for therapeutic use which are considered safe for self-medication but are advised to be available through a pharmacy without a prescription.
SUSMP schedule 3?
Pharmacist Only Medicine: These are substances and preparations for therapeutic use that do not require a prescription but must be sold by a pharmacist.
SUSMP schedule 4?
Prescription Only Medicine: These are substances and preparations that require a prescription from an authorized healthcare professional (such as a doctor or dentist) to be dispensed.
SUSMP schedule 5?
Caution Substances: These are substances with a low to moderate hazard that require caution in handling, use, and storage to reduce the risk of causing harm.
SUSMP schedule 6?
Poison Substances: These are substances that have a moderate to high toxicity and risk of causing harm but are still commonly needed for industrial, agricultural, or domestic purposes.
SUSMP schedule 7?
Dangerous Poisons: These substances are highly hazardous and possess a high risk of causing harm at low exposure levels. They are used in specific, controlled conditions due to their significant risk to health.
SUSMP schedule 8?
Controlled Drugs: These are drugs that have a high risk of abuse, dependence, and addiction but are also recognized for their therapeutic value. They require strict regulation to prevent misuse while allowing them to be available for medical use.
What does pharmacokinetics mean?
Pharmacokinetics: This area of pharmacology deals with the absorption, distribution, metabolism, and excretion (ADME) of drugs. Understanding these processes helps in determining the doses and routes of administration for drugs to achieve optimal therapeutic effectiveness without causing toxicity.
What does pharmacodynamics mean?
Pharmacodynamics: This involves the study of the biochemical and physiological effects of drugs on the body. It examines how drugs exert their effects, including the mechanism of action at the molecular, cellular, and system levels.
Whats is affinity?
Definition: Affinity is a measure of how well a drug binds to its receptor. It reflects the strength of the interaction between a drug and its receptor. A higher affinity means that the drug binds more tightly to the receptor, which usually results in the need for a lower concentration of the drug to achieve a therapeutic effect.