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biotechnology final
| Question | Answer |
|---|---|
| Safety + Dosage | Phase I |
| First time drug is tested in humans | Phase I |
| Looks for side effects, toxicity, how the drug moves in the body | Phase I |
| Gradually increase the dose | Phase I |
| 20–80 participants | Phase I |
| Usually healthy volunteers | Phase I |
| Effectiveness | Phase II |
| Tests whether the drug improves the condition | Phase II |
| Measures short-term side effects | Phase II |
| May compare different doses | Phase II |
| Sometimes randomized and controlled | Phase II |
| 100–300 participants | Phase II |
| Patients with the disease | Phase II |
| Comparison to standard therapy / gold standard | Phase III |
| Largest, most expensive phase | Phase III |
| Tests safety AND effectiveness on a large scale | Phase III |
| Compares to existing treatments, placebos, or both | Phase III |
| Required for FDA approval | Phase III |
| 1,000–3,000+ participants | Phase III |
| Large patient populations across multiple locations | Phase III |
| Post-marketing surveillance | Phase IV |
| Happens AFTER FDA approval | Phase IV |
| Long-term safety | Phase IV |
| Rare side effects | Phase IV |
| Real-world effectiveness | Phase IV |
| Can result in drug recall if serious issues discovered | Phase IV |
| Thousands to millions | Phase IV |
| Denaturation (≈95°C) | DNA strands separate |
| Annealing (~50–65°C, depends on primer Tm) target | primers bind to target |
| Extension (≈72°C) | DNA polymerase synthesizes new strand |
| Amplifies the target region | PCR accomplishes |
| Can introduce restriction sites via primers | PCR accomplishes |
| Produces enough DNA for cloning or sequencing | PCR accomplishes |
| Bright band | high concentration of product |
| Faint band | low concentration or partial amplification |
| Smearing | degraded DNA or too much template/primer-dimer |
| Correct product size | predicted bp length between primers |
| Patent Is | A legal, government-issued protection that gives the inventor exclusive rights to make, use, or sell the invention. |
| key features of patent | Requires full public disclosure of how the invention works |
| key features of patent | Protects for ~20 years from filing |
| key features of patent | After expiration → anyone can use it |
| Trade Secret Is | A private, confidential formula or process that gives a company a competitive advantage. |
| key features of trade secrets | Not registered with the government |
| key features of trade secrets | No expiration — can last forever |
| key features of trade secrets | Protection exists as long as the secret is kept |
| Somatic Cell Nuclear Transfer (SCNT) | a cloning technique where the nucleus of an adult somatic cell is transferred into an egg cell that has had its own nucleus removed. |
Created by:
zahriabeshea
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