Biopharmaceutical là thuốc gì
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Discussion in 'EHC StartUp' started by LOBBY.VN, Dec 8, 2010.
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Thuốc V Biotech là thuốc gì? Thuốc V Biotech có tác dụng gì? Những thông tin bạn đang băn khoăn này sẽ được cung cấp qua bài viết bên dưới. Thành phần thuốc v-biotechCholecalciferol (Vitamin D3) 1 giọt………500IU 1ml………….15000IU 10ml………….150000IU Phụ liệu: Nước cất vừa đủ Công dụngGiúp phòng ngừa và làm giảm triệu chứng thiếu hụt Vitamin D. Hỗ trợ hấp thụ canxi ở trẻ em, phòng ngừa còi xương. Cách dùng thuốc V Biotech
Chú ý: Nhỏ giọt Vitamin D3( cần để lọ nghiêng 45 độ khi nhỏ giọt) vào thìa nhỏ, có thể được uống trực tiếp hay pha với các chất lỏng, Không nên pha với nước quá nóng hay đun sôi hay cho vào thức ăn quá nóng, không nên pha vào bình uống sữa hay nước của trẻ, vì Vitamin D3 có thể bám trên thành bình. Lưu ý: Sản phẩm này không phải là thuốc, không có tác dụng thay thế thuốc chữa bệnh. Đối tượng nào nên dùng thuốc V Biotech?Người bị thiếu hụt vitamin D3, trẻ còi xương do thiếu calci. Phụ nữ có thai và cho con bú, người cao tuổi phòng thiếu calci. Thuốc V Biotech giá bao nhiêu?Hiện nay vẫn chưa cập nhật được giá chính thức. Nếu có thông tin về giá cả chính thức của sản phẩm, xin vui lòng comment bên dưới. Mua V Biotech ở đâu?Có thể tìm mua sản phẩm tại các tiệm thuốc tây, các siêu thị hoặc các cửa hàng thực phẩm chức năng trên toàn quốc. Bảo quản Nơi khô mát, dưới 25 độ C, tránh ánh sáng, đóng nắp kín, không bảo quản trong tủ lạnh. Để xa tầm tay trẻ em. Chất liệu bao bì Sản phẩm được đóng lọ thủy tinh đảm bảo vệ sinh, đạt yêu cầu về vệ sinh an toàn thực phẩm theo quy định của Bộ Y tế. Quy cách đóng gói Lọ 10ml, lọ 15ml, lọ 20ml, lọ 50ml. Hộp 1 lọ. Xuất xứ và thương nhân chịu trách nhiệm về chất lượng hàng hóa: Công Ty Cổ Phần công nghệ sinh phẩm Nam Việt Những thông tin trên chỉ mang tính chất tham khảo. Bệnh nhân không được tự ý áp dụng những thông tin này, việc sử dụng thuốc phải tuân theo chỉ định của bác sĩ và người có chuyên môn.
E hospital là chuyên trang được thành lập bởi đội ngũ y sĩ , bác sĩ giàu năm kinh nghiệm , làm việc tại các bệnh viện lớn tại Việt Nam như bệnh viện E, bệnh viện y học cổ truyền, bệnh viện quân y 108... biopharmaceutical industry biopharmaceutical products biopharmaceutical business biopharmaceutical manufacturing biopharmaceutical firm services company "Biologics" redirects here. For the journal, see Biologics (journal). A biopharmaceutical, also known as a biologic(al) medical product,[1] or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.[2][3] Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source.[4][5][6] Biopharmaceutics is pharmaceutics that works with biopharmaceuticals. Biopharmacology is the branch of pharmacology that studies biopharmaceuticals. Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics.[7][8][9] The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering",[10] including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof.[11] Within EMA contexts, the term advanced therapies refers specifically to ATMPs, although that term is rather nonspecific outside those contexts.
Gene-based and cellular biologics, for example, often are at the forefront of biomedicine and biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.[12] In some jurisdictions, biologics are regulated via different pathways from other small molecule drugs and medical devices.[13] Some of the oldest forms of biologics are extracted from the bodies of animals, and other humans especially. Important biologics include:
Some biologics that were previously extracted from animals, such as insulin, are now more commonly produced by recombinant DNA. Produced by recombinant DNASee also: Biologics for immunosuppression Biologics can refer to a wide range of biological products in medicine. However, in most cases, the term is used more restrictively for a class of therapeutics (either approved or in development) that are produced using biological processes involving recombinant DNA technology. These medications are usually one of three types:
Biologics as a class of medications in this narrower sense have had a profound impact on many medical fields, primarily rheumatology and oncology, but also cardiology, dermatology, gastroenterology, neurology, and others. In most of these disciplines, biologics have added major therapeutic options for treating many diseases, including some for which no effective therapies were available, and others where previously existing therapies were inadequate. However, the advent of biologic therapeutics has also raised complex regulatory issues (see below), and significant pharmacoeconomic concerns because the cost for biologic therapies has been dramatically higher than for conventional (pharmacological) medications. This factor has been particularly relevant since many biological medications are used to treat chronic diseases, such as rheumatoid arthritis or inflammatory bowel disease, or for the treatment of otherwise untreatable cancer during the remainder of life. The cost of treatment with a typical monoclonal antibody therapy for relatively common indications is generally in the range of €7,000–14,000 per patient per year. Older patients who receive biologic therapy for diseases such as rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis are at increased risk for life-threatening infection, adverse cardiovascular events, and malignancy.[14] The first such substance approved for therapeutic use was biosynthetic "human" insulin made via recombinant DNA. Sometimes referred to as rHI, under the trade name Humulin, was developed by Genentech, but licensed to Eli Lilly and Company, who manufactured and marketed it starting in 1982. Major kinds of biopharmaceuticals include:
Research and development investment in new medicines by the biopharmaceutical industry stood at $65.2 billion in 2008.[15] A few examples of biologics made with recombinant DNA technology include:
VaccinesMain article: Vaccine Many vaccines are grown in tissue cultures. Gene therapyViral gene therapy involves artificially manipulating a virus to include a desirable piece of genetic material. Main article: Biosimilar With the expiration of many patents for blockbuster biologics between 2012 and 2019, the interest in biosimilar production, i.e., follow-on biologics, has increased.[16] Compared to small molecules that consist of chemically identical active ingredients, biologics are vastly more complex and consist of a multitude of subspecies. Due to their heterogeneity and the high process sensitivity, originators and follow-on biosimilars will exhibit variability in specific variants over time. The safety and clinical performance of both originator and biosimilar biopharmaceuticals must remain equivalent throughout their lifecycle.[17][18] Process variations are monitored by modern analytical tools (e.g., liquid chromatography, immunoassays, mass spectrometry, etc.) and describe a unique design space for each biologic. Biosimilars require a different regulatory framework compared to small-molecule generics. Legislation in the 21st century has addressed this by recognizing an intermediate ground of testing for biosimilars. The filing pathway requires more testing than for small-molecule generics, but less testing than for registering completely new therapeutics.[19] In 2003, the European Medicines Agency introduced an adapted pathway for biosimilars, termed similar biological medicinal products. This pathway is based on a thorough demonstration of comparability of the product to an existing approved product.[20] Within the United States, the Patient Protection and Affordable Care Act of 2010 created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.[19][21] Researchers are optimistic that the introduction of biosimilars will reduce medical expenses to patients and the healthcare system.[16] When a new biopharmaceutical is developed, the company will typically apply for a patent, which is a grant to exclusive manufacturing rights. This is the primary means by which the drug developer can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on the requirements for a patent, with the European requirements perceived as more difficult to satisfy. The total number of patents granted for biopharmaceuticals has risen significantly since the 1970s. In 1978 the total patents granted was 30. This had climbed to 15,600 in 1995, and by 2001 there were 34,527 patent applications.[22] In 2012 the US had the highest IP (Intellectual Property) generation within the biopharmaceutical industry, generating 37 percent of the total number of granted patents worldwide; however, there is still a large margin for growth and innovation within the industry. Revisions to the current IP system to ensure greater reliability for R&D (research and development) investments is a prominent topic of debate in the US as well.[23] Blood products and other human-derived biologics such as breast milk have highly regulated or very hard-to-access markets; therefore, customers generally face a supply shortage for these products. Institutions housing these biologics, designated as 'banks', often cannot distribute their product to customers effectively.[24] Conversely, banks for reproductive cells are much more widespread and available due to the ease with which spermatozoa and egg cells can be used for fertility treatment.[25] Biopharmaceuticals may be produced from microbial cells (e.g., recombinant E. coli or yeast cultures), mammalian cell lines (see Cell culture) and plant cell cultures (see Plant tissue culture) and moss plants in bioreactors of various configurations, including photo-bioreactors.[26] Important issues of concern are cost of production (low-volume, high-purity products are desirable) and microbial contamination (by bacteria, viruses, mycoplasma). Alternative platforms of production which are being tested include whole plants (plant-made pharmaceuticals). TransgenicsMain article: Pharming (genetics) A potentially controversial method of producing biopharmaceuticals involves transgenic organisms, particularly plants and animals that have been genetically modified to produce drugs. This production is a significant risk for its investor due to production failure or scrutiny from regulatory bodies based on perceived risks and ethical issues. Biopharmaceutical crops also represent a risk of cross-contamination with non-engineered crops, or crops engineered for non-medical purposes. One potential approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk, blood, or urine. Once an animal is produced, typically using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome.[27] The first such drug manufactured from the milk of a genetically modified goat was ATryn, but marketing permission was blocked by the European Medicines Agency in February 2006.[28] This decision was reversed in June 2006 and approval was given August 2006.[29] In the European Union, a biological medicinal product[30] is one of the active substance(s) produced from or extracted from a biological (living) system, and requires, in addition to physicochemical testing, biological testing for full characterisation. The characterisation of a biological medicinal product is a combination of testing the active substance and the final medicinal product together with the production process and its control. For example:
United StatesIn the United States, biologics are licensed through the biologics license application (BLA), then submitted to and regulated by the FDA's Center for Biologics Evaluation and Research (CBER) whereas drugs are regulated by the Center for Drug Evaluation and Research. Approval may require several years of clinical trials, including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks. The manufacture process must satisfy the FDA's "Good Manufacturing Practices", which are typically manufactured in a cleanroom environment with strict limits on the amount of airborne particles and other microbial contaminants that may alter the efficacy of the drug.[31] CanadaIn Canada, biologics (and radiopharmaceuticals) are reviewed through the Biologics and Genetic Therapies Directorate within Health Canada.[32]
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