Biopharmaceuticals

Development of optimized pediatric formulations for oral administration can be challenging, time consuming, and financially intensive process. Since its inception, the biopharmaceutical classification system (BCS) has facilitated the development of oral drug formulations destined for adults. At least theoretically, the BCS principles are applied also to pediatrics. A comprehensive age-appropriate BCS has not been fully developed.

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Cutaneous adverse reactions (CARs) from antiepileptic drugs (AEDs) are common, ranging from mild to life-threatening, including Stevens–Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The identification of subjects carrying the HLA-B*15:02, an inherited allelic variant of the HLAB gene, and the avoidance of carbamazepine (CBZ) therapy in these subjects are strongly associated with a decrease in the incidence of carbamazepine-induced SJS/TEN. In spite of the strong genetic associations, the initiation of hypersensitivity for AEDs is still not very well characterized.

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Advances in our understanding of the molecular principles underlining both health and disease has revealed the existence of many regulatory polypeptides of significant medical potential. The fact that such polypeptides are produced naturally within the body only in minute quantities initially precluded their large-scale medical application. The development in the 1970s of the twin techniques of genetic engineering and hybridoma technology marked the birth of the modern biotech era.

570p ozon_ozon 02-05-2012 99 32   Download

Before the days of mass literacy, medicine was more art than science, and people recognized a pharmacy by the four traditional colored bottles that represent earth, fire, air, and water. Medicine has come a long way since the days of the apothecary with its impressive collection of powders and bottles; drugs today are highly regulated and must comply with standards set by the U.S., Europe, Japan, and other countries. A drug must be shown to be efficacious and meet rigorous standards of purity, composition, and potency before being approved for use in the patient populatio...

400p gian_anh 18-10-2012 39 9   Download

The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the first regulatory agency to publish guidance for industry describing how to meet criteria for requesting a waiver of in vivo bioavailability and bioequivalence studies for highly soluble, highly permeable (BCS Class I) drugs.

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The current studies entail systematic quality by design (QbD)-based development of stimuliresponsive gastroretentive drug delivery systems (GRDDS) of acyclovir using polysaccharide blends for attaining controlled drug release profile and improved patient compliance. The patient-centric quality target product profile was defined and critical quality attributes (CQAs) earmarked.

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Nowadays, there is a growing interest in innovative and more efficient therapeutics—biopharmaceuticals, based on peptides or proteins. There are increased demands on quality control of such therapeutics. One of the methods usually used for characterization and quantification of biopharmaceuticals is amino acid analysis

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Biotechnology is the scientific field of studying and applying the most efficient methods and techniques to get useful end-products for the human society by using viable micro-organisms, cells, and tissues of plants or animals, or even certain functional components of their organisms, that are grown in fully controlled conditions to maximize their specific metabolism inside fully automatic bioreactors.

288p ktct_1669 09-05-2012 190 51   Download

The document English in Pharmacy - Part 2 include all of the following: Biotechnology and biopharmaceuticals, biosimilar medicines, prescritions inserts, reading OTC medicines labels, most common forms of medication, types of medication,...

34p tangtuy14 04-06-2016 138 47   Download

In the mid-1990s plant biotechnology burst onto the scene in world agriculture, beginning a second ‘green revolution’ and precipitating one of the great public debates of our time. Approximately a decade later, this book describes the impact of genetically modified (GM) crops on world agriculture, recent advances in the technology and the areas of research from which the next generation of GM crops is likely to emerge, as well as addresses the issues of safety and regulation that have dogged the technology, particularly in Europe.

307p codoc_pn87 24-11-2012 98 41   Download

It is my privilege to contribute the foreword for this unique volume entitled: “Plant Tissue Culture Engineering,” edited by S. Dutta Gupta and Y. Ibaraki. While there have been a number of volumes published regarding the basic methods and applications of plant tissue and cell culture technologies, and even considerable attention provided to bioreactor design, relatively little attention has been afforded to the engineering principles that have emerged as critical contributions to the commercial applications of plant biotechnologies.

469p codoc_pn87 24-11-2012 71 22   Download

The current text deals with several, very important topics of modern, Analytical Chemistry, such as analytical method validation in biotechnology today, principal component analysis, kinetic methods of analysis using potentiometric and spectrophotometric detectors, the current status of Analytical Chemistry and where it may move in the future, peptide and amino acid separations and identification, and several other, related topics in this growing and increasingly important area of Chemistry, in general.

154p camchuong_1 04-12-2012 56 15   Download

Preformulation is a bridge between discovery and development where development scientists participate in selection and optimization of lead compounds. It is very critical at this stage to evaluate the developability of potential drug candidates in order to select new chemical entities and decrease the number of failures during future drug development. On average, only one out of ten new chemical entities (NCE) entering firstin-human testing reaches registration, approval, and marketing stage.

27p bigbaby87 03-09-2010 75 11   Download

Những tiến bộ trong sự hiểu biết của chúng ta về các nguyên tắc phân tử nhấn mạnh cả về sức khỏe và bệnh tật đã tiết lộ sự tồn tại của polypeptide điều tiết của y học tiềm năng đáng kể.

57p kimku12 26-10-2011 60 11   Download

Chuẩn bị dược phẩm sinh học khác nhau mà con người albumin huyết thanh (HSA) đã được mô tả như là một chất ổn định tiềm năng và b-Interferons g-Interferon Interleukin-2 Urokinase Erythropoietin mô hoạt hóa plasminogen Tumour yếu tố hoại tử đơn dòng kháng thể chuẩn bị g-Globulin chuẩn bị viêm gan B kháng nguyên bề mặt

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Đang thực hiện thử nghiệm lâm sàng là có khả năng mở rộng đáng kể việc sử dụng y tế của những phân tử này quy định trong vài năm tới. Trong khi một số các ứng dụng điều trị tiềm năng được đánh giá cao như xa trở lại như cuối những năm 1950, ứng dụng trị liệu ban đầu đã được trả lại không thực tế do rất thấp

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Các sản phẩm được liệt kê trong các pharmacopoeias quốc tế không thay đổi loại thuốc generic (nghĩa là thuốc không còn được bảo vệ bằng sáng chế, có thể được sản xuất tại bất kỳ cơ sở dược phẩm giữ giấy phép sản xuất thích hợp). Số lượng lớn lớn các chất đó là loại thuốc hóa chất truyền thống, và các chất sinh học như insulin và các sản phẩm máu khác nhau.

57p kimku12 26-10-2011 62 9   Download

Giao hàng tận nơi và sự hấp thu tế bào của chính quyền oligonucleotides Oligo trong nhiều thử nghiệm lâm sàng đòi hỏi trực tiếp iv truyền dịch, thường là qua một khóa học vài giờ. Mặc dù tương đối ổn định trong huyết thanh, thường được sử dụng oligos phosphorothioate (và thực tế hầu hết các loại oligo khác) gặp phải một số rào cản để đạt được điểm đến cuối cùng của họ

57p kimku12 26-10-2011 46 8   Download

.Open source software in life science research Published by Woodhead Publishing Limited, 2012 .Woodhead Publishing Series in Biomedicine 1 Practical leadership for biopharmaceutical executives J. Y. Chin 2 Outsourcing biopharma R&D to India P. R. Chowdhury 3 Matlab® in bioscience and biotechnology L. Burstein 4 Allergens and respiratory pollutants Edited by M. A. Williams 5 Concepts and techniques in genomics and proteomics N. Saraswathy and P. Ramalingam 6 An introduction to pharmaceutical sciences J.

583p hoangnh76 16-07-2013 124 8   Download

Điều chỉnh xuống của các phản ứng pH 4.3 kết quả về lượng mưa của các axit kết quả vòng 6-aminopenicillanic, mà sau đó có thể dễ dàng thu hoạch. Sidechains cuốn tiểu thuyết sau đó có thể được đính kèm, sinh bán tổng hợp penicillin. Ví dụ thứ hai bao gồm phenethicillin, propicillin và oxacillin.

57p kimku12 26-10-2011 38 7   Download