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Word 68KB
Word 68KB

... Resubmission to request an Authority Required (STREAMLINED) listing for the treatment of rheumatoid arthritis and psoriasis for use in patients where the oral tablet form of methotrexate is ...
PDF version of March 2015 PBAC Meeting Agenda
PDF version of March 2015 PBAC Meeting Agenda

... Consumers will have the opportunity to provide comments on new drug submissions (item 5), changes to listings (item 6) and re-submissions (item 7). In many circumstances, consumers will be able to comment on items in other sections of the agenda. The submissions for which input is sought will be lis ...
Biowaiver monographs for immediate release solid oral dosage forms
Biowaiver monographs for immediate release solid oral dosage forms

... Stewart et al.[47] using a single-pass intestinal rat perfusion technique, measured the wall permeability, Pw, for acetaminophen to be 0.86 ± 0.5 × 10-4 cm/s and they estimated the fraction absorbed to be 80%. Using rat perfusions, Lu et al.[48] estimated the dimensionless wall permeability, , of ac ...
Guidelines on the quality, safety, and efficacy of biotherapeutic
Guidelines on the quality, safety, and efficacy of biotherapeutic

... manufacturing and quality control in these guidelines may apply to protein-based vaccine antigens made by rDNA technology. However, more detailed guidelines/recommendations on vaccine evaluation in terms of quality, safety and efficacy should be consulted (2, 3). Other product-specific vaccine-relat ...
pharmaceutical compounding-nonsterile preparations
pharmaceutical compounding-nonsterile preparations

... 4 units and such that the expected pH of the material under test falls between them. Fill the cell with one of the Buffer Solutions for Standardization at the temperature at which the test material is to be measured. Set the “temperature” control at the temperature of the solution, and adjust the ca ...
psychiatric aspects of marihuana intoxication
psychiatric aspects of marihuana intoxication

... men of imagination, and descriptions of its effects upon the mind and body have been given in popular and scientific literature countless times. The literature has been adequately considered by Walton (1) and by Bromberg (2), and will therefore not be reviewed at the present time. ...
A Retrospective Study of Buprenorphine and
A Retrospective Study of Buprenorphine and

... of treatment compliance and recidivism. Hair may serve as a historical record of drug exposures (1-3). It has been proposed that knowing the rate of hair growth in an individual and the location of the drug along the long axis of the hair shaft will allow determination of the approximate time of dru ...
Chapter  Pharmaceutical Compounding – Nonsterile
Chapter Pharmaceutical Compounding – Nonsterile

... The compounder is responsible for compounding preparations of acceptable strength, quality, and purity and in accordance with the prescription or medication order. The compounder is also responsible for dispensing the finished preparation, with appropriate packaging and labeling, and in compliance w ...
Document
Document

... water samples were conducted in less polluted pond at Sarawak Golf Club UNIMAS to isolate non­ pathogenic amoeba. Stepwise optimisation to initial amoeba isolation protocol resulted in a protocol which was applied successful to isolate and culture amoeba. The antiamoebic activity was conducted by tr ...
Foundation - The Learning Oasis
Foundation - The Learning Oasis

... the body and Edward Jenner invented a vaccination for smallpox after discovering the relationship between cowpox and smallpox. Each major capital city in Europe published a list of commonly used drugs. The most notable of these is the one created in Great Britain, Martindale’s Pharmacopoeia. It was ...
The CFC to HFA Transition and Its Impact on
The CFC to HFA Transition and Its Impact on

... in 1974.8 Ironically, it received little attention until Rowland and Molina held a press conference and The New York Times published several articles on their work. The United States formed the Inadvertent Modification of the Stratosphere task force with the involvement of the United States Environm ...
Single-Amino Acid Substitutions Alter the Specificity and Affinity of
Single-Amino Acid Substitutions Alter the Specificity and Affinity of

... ABSTRACT: PDZ domains are modular protein-protein interaction domains that bind to specific C-terminal sequences of membrane proteins and/or to other PDZ domains. Certain PDZ domains in PSD-95 and syntrophins interact with C-terminal peptide ligands and heterodimerize with the extended nNOS PDZ doma ...
Target Regimen Profiles for TB Treatment
Target Regimen Profiles for TB Treatment

... There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of target product profiles for TB drug regimens (hereafter referred as target regimen profiles) is meant to assist drug regimen developers in identifying important regi ...
Manal Alsaadi Research Day Poster
Manal Alsaadi Research Day Poster

... is the leading cause of cancer death claiming the lives of 1.3 million patients a year worldwide [1]. Lung cancer is mainly treated by cisplatin, where it is presently administered as an intravenous infusion over 6-8 hours. This results in entire body exposure leading to undesirable and chronic side ...
Lab 6
Lab 6

... paraffin is used for water-soluble bases and a water-soluble lubricant such as soft-soap ethanol solution (soft soap: glycerin: 90% ethanol 1:1: 5) is used for fatty bases. Every mold is capable of holding a specific volume of materials in each of its openings. Because of the difference in the densi ...


... Minnie Baylor-Henry, CDER, Director, Divisj-on of Drug Marketing and Advertising ...
THE PROMISE OF IMAGING BIOMARKERS
THE PROMISE OF IMAGING BIOMARKERS

... are used to visualize proteins, dominate early discovery work and are used in assessing target expression and function as well as compound screening and lead discovery. Preclinical animal studies - focused more on efficacy, toxicity, pharmacokinetics and pharmacodynamics - rely more on PET, SPECT, M ...
DOCTORAL THESIS
DOCTORAL THESIS

... peptoid hits that showed activity as uncompetitive TRPV1 antagonists, and that allowed to propose a basic pharmacophoric hypothesis consisting on one cationic and two identical aromatic moieties, this thesis focused on the design and synthesis of new antagonists with a more rigid non-peptoid structu ...
Crystal structure of ATP sulfurylase from Saccharomyces cerevisiae
Crystal structure of ATP sulfurylase from Saccharomyces cerevisiae

... by hydrogen bonds and salt bridges. Contacts between the residues of helix H3 and the coiled region preceding H11 of the interdomain show a more hydrophobic character. Domain II (residues 168±327) comprises the active site and the substrate binding pocket. It shows a typical righthanded a/b-fold in ...
Marijuana
Marijuana

... 2737 B.C. Early writings in China note prescribing marijuana to treat every thing from gout to absentmindedness. 1600s American Colonies mandated the growth of Cannabis Sativa for the hemp which was needed for rope and fabric among other things. 1765 George Washington thought to use cannabis for hem ...
DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR SIMULTANEOUS
DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR SIMULTANEOUS

... esophagitis and in this way control nausea and vomiting. Thus, the pharmacology of Pantoprazole and Cinitapride corroborates their use in combined dosage form to treat various gastro intestinal disorders in particular for hyperacidity frequently associated with gastro intestinal dysmotility1. Spectr ...
GBL
GBL

... ③ Feb. 2009 Presented to ED, Self-discharged before seen ④ April 2009 BIBA following GHB and methamphetamine use. Agitated and hyperventilating, given IV diazepam and self-discharged ⑤ May 2009 Admitted in coma (GCS 3). Crash intubation, ventilated on ITU and self-discharged from step-down ⑥ May 200 ...
Proposed new ICH and USP methods for elemental impurities
Proposed new ICH and USP methods for elemental impurities

... as ICP-OES or ICP-MS referenced in USP<233> [7]. However, many drug products will require acid digestion, with its associated dilution of the original sample, which means that the concentrations measured in the sample solution presented to the instrument will be significantly lower than the PDE limit ...
Review Article Amla (Emblica officinalis) – Medicinal Food and
Review Article Amla (Emblica officinalis) – Medicinal Food and

... Emblica officinalis is a natural, efficacious an antioxidant with the richest natural source of Vitamin C (200‐900 mg per 100 g of edible portion). Numerous studies conducted on Emblica officinalis fruit suggest that it has anti-viral properties and also functions as an anti-bacterial and anti-funga ...
preparation of diazepam rectal gel using cellulose polymers
preparation of diazepam rectal gel using cellulose polymers

... Accelerated stability testing using the Arrhenius relationship is often employed for stability parameter identification. The well-known classical approach consists of sequential steps, including the determination of the kinetic constant KT for the correct order of the degradation reaction. This is d ...
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Drug design



Drug design, sometimes referred to as rational drug design or simply rational design, is the inventive process of finding new medications based on the knowledge of a biological target. The drug is most commonly an organic small molecule that activates or inhibits the function of a biomolecule such as a protein, which in turn results in a therapeutic benefit to the patient. In the most basic sense, drug design involves the design of molecules that are complementary in shape and charge to the biomolecular target with which they interact and therefore will bind to it. Drug design frequently but not necessarily relies on computer modeling techniques. This type of modeling is often referred to as computer-aided drug design. Finally, drug design that relies on the knowledge of the three-dimensional structure of the biomolecular target is known as structure-based drug design. In addition to small molecules, biopharmaceuticals and especially therapeutic antibodies are an increasingly important class of drugs and computational methods for improving the affinity, selectivity, and stability of these protein-based therapeutics have also been developed.The phrase ""drug design"" is to some extent a misnomer. A more accurate term is ligand design (i.e., design of a molecule that will bind tightly to its target). Although design techniques for prediction of binding affinity are reasonably successful, there are many other properties, such as bioavailability, metabolic half-life, side effects, etc., that first must be optimized before a ligand can become a safe and efficacious drug. These other characteristics are often difficult to predict with rational design techniques. Nevertheless, due to high attrition rates, especially during clinical phases of drug development, more attention is being focused early in the drug design process on selecting candidate drugs whose physicochemical properties are predicted to result in fewer complications during development and hence more likely to lead to an approved, marketed drug. Furthermore, in vitro experiments complemented with computation methods are increasingly used in early drug discovery to select compounds with more favorable ADME (absorption, distribution, metabolism, and excretion) and toxicological profiles.
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