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Welcome to the Pubget Medical Subject Headings (MESH) browser. Click on a topic or subtopic below to explore related papers. In the gold box is the most recent paper about the current MESH term, and below are 20 related papers.
Biopharmaceutics (0):
Recent article
Biopharmaceutics
Abstract
2,3,9,10-Tetramethoxy-12-oxo-12-H-indolo[2,1-a]isoquinolinium chloride 1 (compound X) and 13-(3,4-dimethoxyphenyl)-2,3,8,9-tetramethoxy-6a, 12a-diazadibenzo[a,g] fluorenylium chloride 2 (compound NF) are new papaverine oxidation products. A solution of compound 1 bleaches on addition...
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PMID: 21553644
PDF is available here.
PDF is available here.
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YAKUGAKU ZASSHI (130)6 2010
Abstract
We have shown that aqueous arginine solution increases the solubility of proteins in formulation and purification, suppresses aggregation during refolding and storage and improves performance of column chromatography. Acidic arginine solution now finds application for virus inactivation. I will summ...
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PMID: 20519857
PDF is available here.
PDF is available here.
Bulletin du cancer (97)5 2010
Abstract
Although few molecules are available, annual total sales of biotechnology drugs amounted 71 billion $ in 2008) and knew a 17% progression per year. As traditional drugs had their generic, many biotechnology drugs had or will lose their patent and be copied, called "biosimilars" or "follows-on". Acco...
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PMID: 20385522
PDF is available here.
PDF is available here.
Abstract
The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of Biopharmaceutics, the certification of Food and Drug Administration authority over the functions i...
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PMID: 19936940
PDF is available here.
PDF is available here.
Abstract
I will also briefly review some recent uses of the technology to illustrate its incredible versatility....
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PMID: 20196239
PDF is available here.
PDF is available here.
AAPS Journal (12)1 2010
Abstract
The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of Biopharmaceutics, the certification of Food and Drug Administration authority over the functions i...
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PMID: 19936940
PDF is available here.
PDF is available here.
AAPS Journal (12)1 2010
Abstract
The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of Biopharmaceutics, the certification of Food and Drug Administration authority over the functions i...
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PMID: 19936940
PDF is available here.
PDF is available here.
AAPS Journal (12)1 2010
Abstract
The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of Biopharmaceutics, the certification of Food and Drug Administration authority over the functions i...
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PMID: 19936940
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (60)9 2010
Abstract
I (highly soluble/highly permeable) drug substances, which represent up to 25% of the drugs. Efforts in both the science and regulatory bodies are being made to extend biowaivers to certain Class II and III products, which would represent more than 50% of all drugs coming to the market. The aim of t...
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PMID: 21117498
PDF is available here.
PDF is available here.
Abstract
The prime difference between generics and biosimilars is that while generics contain the exact active ingredient as in the originator product, biosimilars are only "similar" and not "identical" to the originator biological medicine. This difference appears due to the nature of the biopharmaceutical...
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PMID: 19939216
PDF is available here.
PDF is available here.
Abstract
The primary objective of Safety Pharmacology is to ensure the safety of medicines on physiological functions in order to protect humans against adverse drug reactions. Safety Pharmacology became a major non-clinical discipline in 2000 when the International Conference on Harmonization approved the S...
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PMID: 19998526
PDF is available here.
PDF is available here.
Abstract
Given that biosimilars are similar, but not identical to the reference biopharmaceutical, the development process needs to generate clinical trial data in order to gain marketing authorisation. From a health economic perspective, the question arises whether inherent differences between biopharmaceut...
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PMID: 19723019
PDF is available here.
PDF is available here.
Abstract
Abstract
Poor solubility and poor permeability account for many pharmacokinetic failures and about thirty percent of drug molecules are rejected due to pharmacokinetic failures. When poor pharmaceutical properties are discovered in development, the cost of bringing a potent, but poorly absorbable molecule to...
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PMID: 19746834
PDF is available here.
PDF is available here.
Abstract
Abstract
This report discusses the principles of developmental and reproductive toxicity (DART) testing for biopharmaceuticals. Biopharmaceuticals are large-molecular-weight proteins or peptides produced by modern biotechnology techniques incorporating genetic engineering and hybridoma techno...
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PMID: 19462404
PDF is available here.
PDF is available here.
Abstract
Bioavailability of the extended-release tramadol capsules for once daily administration is not affected by the time-point of administration. Total and maximum exposure of the product was bioequivalent after intake in the morning and at night. Thus, the time-point of administration may be adjusted to...
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PMID: 19473603
PDF is available here.
PDF is available here.
Abstract
We provide some current topics of glycosylated biopharmaceuticals from the viewpoints of efficacy, safety, and the manufacturing process and discuss the significance of glycosylation analysis for development of biopharmaceuticals....
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PMID: 19420744
PDF is available here.
PDF is available here.
Australian Health Review (33)2 2009
Abstract
We argue that the most important feature of the biopharmaceutical industry in these countries is the dominant role of the public sector. That these countries have made progress in innovative capabilities is illustrated by input measures such as R&D expenditure as share of gross domestic product, num...
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PMID: 19563313
PDF is available here.
PDF is available here.
Abstract
Pharmaceuticals have historically been produced by either chemical synthesis or whole cell fermentation. The former is applied to synthetic small molecules while the latter to natural products. As a result of recent advances in rapid discovery of enzymes through genome mining and metagenomics, and t...
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PMID: 19149609
PDF is available here.
PDF is available here.
Abstract
Abstract
Przeglad lekarski (66)10 2009
Abstract
Over one hundred of biopharmaceuticals present on the pharmaceutical market--among them mainly therapeutically peptides and proteins such as hormones, enzymes, interferons, blood factors, monoclonal antibodies, vaccines, growth factors and fusion proteins, are manufactured through recombinant DNA te...
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PMID: 20301965
PDF is available here.
PDF is available here.
Drug Safety (32)10 2009
Abstract
Biopharmaceuticals are important treatment options for a variety of chronic and sometimes life-threatening diseases. Compared with the traditional small molecule drugs, biopharmaceuticals have specific characteristics, which might also influence their safety profile. They have, for example, a comple...
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PMID: 19722725
PDF is available here.
PDF is available here.
Abstract
We investigate whether physicians' beliefs about genetic engineering have any influence on their likelihood of prescribing a biopharmaceutical. A sample of 175 physicians practicing in one state in the mid-south region of the U.S. was selected and their beliefs, importance of genetic modification as...
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PMID: 19813125
PDF is available here.
PDF is available here.
Abstract
A comparative analysis of results of toxicological research of microbiological preparations on the basis of different species of nitrogen-fixing microorganisms of Azotobacter, Agrobacterium, Azospirillum general and pathogenic properties of strains-producers has been carried out. A possibility to im...
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PMID: 20455429
PDF is available here.
PDF is available here.
Abstract
Although toxicology studies should always be conducted in pharmacologically relevant species, the specificity of many biopharmaceuticals can present challenges in identification of a relevant species. In certain cases, that is, when the clinical product is active only in humans or chimpanzees, or if...
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PMID: 19546261
PDF is available here.
PDF is available here.
Nature Biotechnology (27)1 2009
Abstract
Abstract
Recent published evidences on ibuprofen and meloxicam confirm the need of faster oral drug absorption to overcome the pathophysiological conditions associated with dental pain (due to excessive vagal nerve suppression) in order to provide relief in acute pain management. While the communication prov...
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PMID: 19462922
PDF is available here.
PDF is available here.
Abstract
We will present an overview of why physicochemical properties are important, before discussing how the properties are related to each other. Findings are based on research in our own laboratories using our commercial instruments and software to measure the pKa, lipophilicity (LogP) and intrinsic sol...
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PMID: 18991583
PDF is available here.
PDF is available here.
Drug Discovery Today (13)21-22 2008
Abstract
Abstract
The purpose of this mini review is to discuss the use of physiologically-based drug absorption modeling to guide the formulation development. Following an introduction to drug absorption modeling, this article focuses on the preclinical formulation development. Case studies are presented, where the...
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PMID: 18751901
PDF is available here.
PDF is available here.
Abstract
We present a variant of c(s) designed for the purpose of trace detection, with customized Bayesian regularization. The original c(s) method relies on maximum entropy regularization providing the most parsimonious distribution consistent with the data. In the present paper, we use computer simulation...
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PMID: 18814037
PDF is available here.
PDF is available here.
Abstract
I (DI>or=3, PI>or=3), II (DI<3, PI>or=3), III (DI>or=3, PI<3) and IV (DI<3, PI<3). In conclusion, two classification systems were developed, one for NMEs based on solubility/dose ratio and permeability estimates and one for marketed drugs based on MDT and MPT estimates....
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PMID: 18614303
PDF is available here.
PDF is available here.
Abstract
A method for log D (pH 7.4) measurement was developed using microfluidic liquid-liquid extraction. Values were determined for 26 compounds and compared to results obtained via shake-flask methods. Excellent correlation between the values obtained via both methods was achieved (R(2) = 0.994). The dev...
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PMID: 18666772
PDF is available here.
PDF is available here.
Abstract
Semi-synthetic cephalosporin antibiotics have structures similar to that of penicillins, and both groups of compounds are characterized by similar properties and determined by the same methods. Most antibiotics, including cephalosporins and their decomposition products, contain electron donor groups...
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PMID: 18771001
PDF is available here.
PDF is available here.
American Journal of Health-System Pharmacy (65)14 Suppl 6 2008
Abstract
PURPOSE: Scientific issues and clinical implications associated with the use of biosimilars (biopharmaceuticals that are similar to an innovator product, notwithstanding minor differences) are illustrated in two examples, botulinum neurotoxins and erythropoietic agents. SUMMARY: Comparison of Botox...
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PMID: 18591714
PDF is available here.
PDF is available here.
American Journal of Health-System Pharmacy (65)14 Suppl 6 2008
Abstract
PURPOSE: Historical perspective on the use of biotechnology for drug product development, terminology used for biotechnology drug products, potential benefits of biotechnology, applications of biotechnology to drug product development, pharmacy considerations in the use of biopharmaceuticals, and th...
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PMID: 18591711
PDF is available here.
PDF is available here.
American Journal of Health-System Pharmacy (65)14 Suppl 6 2008
Abstract
American Journal of Health-System Pharmacy (65)14 Suppl 6 2008
Abstract
PURPOSE: The regulatory background surrounding biosimilars (biopharmaceuticals that are considered similar in composition to an innovator product, but not necessarily clinically interchangeable); equivalence, interchangeability, and unique considerations associated with biopharmaceuticals; the bioph...
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PMID: 18591712
PDF is available here.
PDF is available here.
Drug Discovery Today (13)13-14 2008
Abstract
Approximately 40% of new chemical entities exhibit poor aqueous solubility and present a major challenge to modern drug delivery system, because of their low bioavailability. Self-emulsifying drug delivery systems (SEDDS) are usually used to improve the bioavailability of hydrophobic drugs. Conventi...
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PMID: 18598917
PDF is available here.
PDF is available here.
Drug Discovery Today (13)13-14 2008
Abstract
Biopharmaceutical drug development is an intricate path that spans a dozen years from discovery through registration. The development of a therapeutic antibody presents substantial challenges, particularly with respect to the creation and implementation of manufacturing process technologies. Process...
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PMID: 18598918
PDF is available here.
PDF is available here.
Pharmaceutical Research (25)7 2008
Abstract
This study has shown the promise of sensitive LC-MS/MS method to support microdose pharmacokinetics and drug metabolism studies in human....
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PMID: 18299965
PDF is available here.
PDF is available here.
Nature Biotechnology (26)7 2008
Abstract
With follow-on biologics essentially dead in the water in the US, the decision of the world's largest generics manufacturer to invest in a platform for enhancing protein pharmacokinetics could pay dividends.
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PMID: 18612272
PDF is available here.
PDF is available here.
Molecules and Cells (25)4 2008
Abstract
Many therapeutic glycoproteins have been successfully generated in plants. Plants have advantages regarding practical and economic concerns, and safety of protein production over other existing systems. However, plants are not ideal expression systems for the production of biopharmaceutical proteins...
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PMID: 18443408
PDF is available here.
PDF is available here.
Nature Biotechnology (26)7 2008
Abstract
Young biotech companies may not need extensive patent portfolios to survive or grow.
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PMID: 18612295
PDF is available here.
PDF is available here.
Nature Biotechnology (26)7 2008
Abstract
Vested interests are redefining, rebranding and co-opting what is 'biopharmaceutical'. This is not just a matter of semantics-the core identity of the biotech industry and its products is at stake.
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PMID: 18612293
PDF is available here.
PDF is available here.
Abstract
The biopharmaceutical classification system (BCS) classifies compounds based on their solubility and permeability. Regulatory agencies and health organizations have utilized this classification system to allow dissolution to be used to establish bioequivalence for highly soluble and highly permeable...
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PMID: 18500563
PDF is available here.
PDF is available here.
Abstract
I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS...
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PMID: 18679807
PDF is available here.
PDF is available here.
Abstract
Quality by design (QbD) has recently been introduced in pharmaceutical product development in a regulatory context and the process of implementing such concepts in the drug approval process is presently on-going. This has the potential to allow for a more flexible regulatory approach based on unders...
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PMID: 18686045
PDF is available here.
PDF is available here.
Abstract
Gamma-irradiation is currently the method of choice for terminal sterilization of drug delivery systems made from biodegradable polymers. However, the consequences of gamma-sterilization on the immune response induced by microencapsulated antigens have not yet been reported in the literature. The ai...
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PMID: 18280123
PDF is available here.
PDF is available here.
Molecular Biotechnology (39)2 2008
Abstract
Social and economical development is closely associated with technological innovation and a well-developed biotechnological industry. In the last few years, Brazil's scientific production has been steadily increasing; however, the number of patents is lagging behind, with technological and translati...
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PMID: 18327551
PDF is available here.
PDF is available here.
Molecular Biotechnology (39)2 2008
Abstract
The production of recombinant therapeutic proteins is one of the fastest growing sectors of the pharmaceutical industry, particularly monoclonal antibodies and Fc-fusion proteins. Currently, mammalian cells are the dominant production system for these proteins because they can perform complex post-t...
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PMID: 18327554
PDF is available here.
PDF is available here.
Georgian medical news ()158 2008
Abstract
The vaginal suppository composition, containing 0, 05, 0, 1 and 0, 5 of drug substance is presented. The release of drug substance was investigated. The influence of a number of the factors on the degree of release was investigated. Cocoa oil, confectionery fat and three different types of emulgator...
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PMID: 18560037
PDF is available here.
PDF is available here.
Abstract
The steady growth of the US biopharmaceutical pipeline and consequent anticipated near-term approvals will increasingly affect third-party portfolio decision making. Cost of therapy, identifying the right drug for the right patient, and outcomes-based value should drive that decision process....
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PMID: 18402515
PDF is available here.
PDF is available here.
Abstract
A rapid solubility-screening assay was developed with a focus on Biopharmaceutic Classification Scheme (BCS) class II drug solubility in animal and simulated human gastrointestinal (GI) fluids. The assay enables biologically promising drug leads to be evaluated for solubility limitations earlier in...
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PMID: 17724660
PDF is available here.
PDF is available here.
Biotechnology Letters (30)2 2008
Abstract
The biopharmaceuticals market is currently outperforming the pharmaceuticals market and is now valued at US$ 48 billion with an average annual growth of 19%. Behind this success is a 100-fold increase in productivities of eukaryotic expression systems. However, the productivity per cell has remained...
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PMID: 17885737
PDF is available here.
PDF is available here.
Abstract
Acute cytokine release syndromes are associated with some therapeutic antibodies in man, leading to a spectrum of clinical signs from nausea, chills and fever to more serious dose limiting hypotension and tachycardia. When anticipated this syndrome is typically manageable, however this adverse react...
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PMID: 18382853
PDF is available here.
PDF is available here.
Abstract
The Biopharmaceutics Classification System (BCS) is not only a useful tool for obtaining waivers for in-vivo bioequivalence studies but also for decision making in the discovery and early development of new drugs. Measurement of solubility and permeability in the discovery/development settings is de...
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PMID: 18446521
PDF is available here.
PDF is available here.