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일/제약 바이오 6

Safety와 Tolerability의 차이 (feat. Chat GPT)

Safety: 약물의 약효(주작용)가 아닌 부작용(Adverse effects)/ 위험의 정도 - 예를 들어 하나의 약에 다양한 효과가 있을 경우, 기대한 효과를 주작용 기대하지 않았던 효과를 부작용이라고 함 - 삭센다의 경우, 최초 개발 시 부작용이 체중 감소였는데 -> 추후 이 부작용을 주작용으로 한 비만 치료제를 개발함 - Safety의 규명은 side effect, 관련 potential risk 를 감수할만큼 약효 (efficacy)가 뛰어난지를 평가하는 목적 Tolerability: 환자 관점에서 환자가 부작용을 견딜 수 있는 정도 - 부작용의 severity, frequency, duration, and impact와 qulaity of life를 고려함 - 환자의 약물의 acceptance..

고양이 관절염 항체 치료제 Solensia (FDA 최초로 승인한 동물용 항체 치료제)

FDA has opened up the new era for animal drugs. I am very confident that pets of a rich family will be treated better than poor human beings. Like monoclonal antibodies for human, monoclonal antibodies for animals will have really good efficacy so it is a really good news for pets and rich family who can afford this type of treatment. The only concern is about side effects. Because cats cannot t..

Acute pain 신약 개발 업체 Heron Therapeutics, 두 개 약물의 FDA 승인

Aponvie : first intravenous P/neurokinin-1 (NK) receptor antagonist - It was a brilliant idea that it significantly enhanced the efficacy of the generic drug by changing the route of administration. - Aponvie’s fast onset of action, and half-life in human brain and convenience for patients (compliance perspective) seem very strong. - However, the market penetration of Aponvie will be deecided by..

NK cell (Natural killer cell)을 활성화시키는 Combi. therapy

1. 내용 Key Highlights When cancer drugs fail, a unique combination of already existing drugs could harness an under-targeted part of the immune system to join the fight A new study led by Penn State College of Medicine scientists finds that another type of immune cell — natural killer cells — can be harnessed to pick up the slack when T cells no longer work and may also reinvigorate T cells to at..

Precision BioSciences의 유전자 편집 기술이 CRISPR의 대항마 될까?

1. 내용 Key Highlights an opportunity to showcase the company’s platform, which was derived from I-CreI, a naturally occurring gene editing enzyme that comes from algae. According to Precision Chief Scientific Officer Derek Jantz, Ph.D., Arcus' X-factor is its ability to make insertions to the genome as opposed to only eliminating gene function. When it comes to leveraging gene editing for rare ge..

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