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| Pregunta | Respuesta |
| Key moments in the history of the pharmaceutical industry | - The modern pharmaceutical industry emerged at an intersection between 3 critical areas: biomedical sciences, chemistry and therapeutics. - 1909- Ehrlich showed syphilis could be treated using arsenic compounds - 60s, 70s, 80s, era of 'rational drug design'; beta blockers, ACE inhibitors 1961- Thalidomide withdrawn 2002- Human genome mapped |
| Key stages in the drug discovery process | 1. Basic research eg in Unis- leads to better understanding of physiology and disease mechanisms 2. Identification of potential drug targets- looking for molecular targets- usually proteins- that play a critical role in the disease 3. Hypothesis generation- 'a drug that acts on its target to change activity will be more effective in treating disease |
| Other considerations in the drug discovery process | - Safety considerations: harm to patients/environment - Ethical issues: is development of the drug conducive to a civilised society - Intellectual property- is the drug covered by a patent? - Cost- does it make buisiness sense to develop a drug to treat a particular condition? |
| Main sources of drugs with examples | Many drugs are, or are derivatives of natural products, while others are synthesised in the pharmaceutical industry Examples: Morphine- opium poppy- analgesia Penicillin- penicillin funghi- antibiotic Dixoxin- digoxin mould- treating heart failiure Botulinium digitoxin- bacterium clostridum botulinum- botox |
| Combinatorial chemistry | Chemicals reacted together from a library. Products mixed and reacted together to create new chemicals |
| High throughput screening | - Using assay techniques to screen compounds in the library in order to identify which compounds have the required biological activity. - Early assays must have the ability to screen lots of compunds quickly, hence the term 'high throughput' screening - Highly automated, often done by robots |
| Structure-activity relationships, and why they are important in the drug discovery process | Structure-activity relationships; aka SARs can be used to optimise the properties of promising drug candidates. - Similar-structured drugs often have similar activities eg morphine, coedine |
| Drug discovery and development: Clinical trials: Pre clinical stages | - Preclinical stages: last about 5-10 years, usually result in 1/2 drug candidates being taken forward into human trials. Patent granted early during this stage & lasts for 20 years |
| Clinical trials: phase 1: exploratory studies in man | - Drug will have already be tested in rodents and mammals, this is the first test in humans. - Involves a small amount of voulenteers, receivingincreasing doses in specialised facilities - This phase is to asses for: Safety- identifying potentially dangerous side effects Tolerability- unpleasant symptoms/side effects |
| Clinical trials: phase II: Proof of concept and safety | - To determine clinical effect of the drug i n patients, as well as confirming safety and tolerability - Phase IIa- exploratory, 50-200 patients, approx 1 yr, dose and regimen based on phase 1 results. Placebo-controlled, randomised , double-blind. - Phase IIb- confirmatory- 200-500 patients, approx 2 yrs. Tests safety and efficacy compared to placebo/current treatment in randomised, double-blind trials. |
| Clinical trials: Phase 3: Confirmatory | - Full scale evaluation of how effective and safe the treatment is compared to current treatment/placebo - Usually 2,000 to 10,000 patients, often in multi centres, including different air groups - Lasts several years - Provides data to support registration |
| Clinical trials: Phase 4: Ongoing clinical trials | - Conducted once drug is licensed and on the market eg pharmacovigilance, post-market surveillance. - Monitors consequences of increasing exposure - Yields info on efficacy in sub-groups of the population |
| Drug regulatory bodies | UK: Medicines and healthcare regulatory agency EU: European medicines agency USA: Food and drug administration FDA |
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