PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board
... Xylometazoline HCl 0.5 mg/ml and 1 mg/ml nasal drops, and Xylometazoline HCl 1 mg/ml nasal spray are locally applied, locally acting medicinal products and therefore fulfil the exemption mentioned in the Note for Guidance on bioequivalence, which states that an exemption for bioequivalence study can ...
... Xylometazoline HCl 0.5 mg/ml and 1 mg/ml nasal drops, and Xylometazoline HCl 1 mg/ml nasal spray are locally applied, locally acting medicinal products and therefore fulfil the exemption mentioned in the Note for Guidance on bioequivalence, which states that an exemption for bioequivalence study can ...
Control Strategies for Synthetic Therapeutic Peptide APIs
... used routinely, most frequently determined from elemental analysis. Kjeldahl analysis or chromatographic methods with chemiluminescence nitrogen detection may also be used. Only peptides containing Trp, Tyr, or Phe residues may lend themselves to assay determination using UV absorbance measurement a ...
... used routinely, most frequently determined from elemental analysis. Kjeldahl analysis or chromatographic methods with chemiluminescence nitrogen detection may also be used. Only peptides containing Trp, Tyr, or Phe residues may lend themselves to assay determination using UV absorbance measurement a ...
Basic Principles of GMP
... Tablet Excipients ….for example, there are various grades of lactose commercially available that have different physical properties, e.g. flow characteristics & particle size distribution. This permits selection of what is considered the most suitable grade for a particular need, e.g. with tablet ...
... Tablet Excipients ….for example, there are various grades of lactose commercially available that have different physical properties, e.g. flow characteristics & particle size distribution. This permits selection of what is considered the most suitable grade for a particular need, e.g. with tablet ...
New Approaches to Chronic Anticoagulation
... • Rivaroxaban was well tolerated, with similar incidence of AEs as enoxaparin • Rivaroxaban did not affect ECG parameters • Rivaroxaban did not have any substance-specific effects on laboratory parameters (except for clotting tests) • LFT increases with BAY 597939 did not exceed the level observed w ...
... • Rivaroxaban was well tolerated, with similar incidence of AEs as enoxaparin • Rivaroxaban did not affect ECG parameters • Rivaroxaban did not have any substance-specific effects on laboratory parameters (except for clotting tests) • LFT increases with BAY 597939 did not exceed the level observed w ...
EXTRA MURAL RESEARCH Search for Potential Anticancer Agents:
... anticancer activity but other products from some other companies did not showed the expected activity with dilutions, even there were discrepancies in results between these two parameters, i.e., % inhibition of cell count and the % inhibition of tumor weight of the ascitic fluid. It may be due to th ...
... anticancer activity but other products from some other companies did not showed the expected activity with dilutions, even there were discrepancies in results between these two parameters, i.e., % inhibition of cell count and the % inhibition of tumor weight of the ascitic fluid. It may be due to th ...
Package Inserts for Prescription Drugs as Evidence in Medical
... The Food and Drug Administration (FDA) requires drug manufacturers to accompany shipments of prescription drugs with "package inserts" that describe the drug, summarize its possible beneficial and harmful effects on the patient, and give the doctor directions for its use.' The insert is directed to ...
... The Food and Drug Administration (FDA) requires drug manufacturers to accompany shipments of prescription drugs with "package inserts" that describe the drug, summarize its possible beneficial and harmful effects on the patient, and give the doctor directions for its use.' The insert is directed to ...
An overview on chemical modification of enzymes. The use of group
... certain amino acid is normally present in an enzyme molecule, making it difficult to achieve selectivity towards one single resi due. To overcome these limitations, researchers doing chemical modification increasingly turn to affinity labels. These compounds are chemically reactive analogs of enzym ...
... certain amino acid is normally present in an enzyme molecule, making it difficult to achieve selectivity towards one single resi due. To overcome these limitations, researchers doing chemical modification increasingly turn to affinity labels. These compounds are chemically reactive analogs of enzym ...
adolescent alcohol and substance use and abuse
... ••Begin with open-ended questions about substance use at home and school and by peers before progressing to open-ended questions about personal use. Two questions that can readily screen for the need to ask further questions include ...
... ••Begin with open-ended questions about substance use at home and school and by peers before progressing to open-ended questions about personal use. Two questions that can readily screen for the need to ask further questions include ...
2(g)
... Reaction in which a compound containing Hydrogen and Carbon are burned to produce H2O(g) and CO2(g). ...
... Reaction in which a compound containing Hydrogen and Carbon are burned to produce H2O(g) and CO2(g). ...
Osmotic-Controlled Release Oral Delivery System
... The osmotic-controlled release oral delivery system, OROS, is an advanced drug delivery technology that uses osmotic pressure as the driving force to deliver pharmacotherapy, usually once-daily, in several therapeutic areas. Oral route is one of the most extensively used routes of drug administratio ...
... The osmotic-controlled release oral delivery system, OROS, is an advanced drug delivery technology that uses osmotic pressure as the driving force to deliver pharmacotherapy, usually once-daily, in several therapeutic areas. Oral route is one of the most extensively used routes of drug administratio ...
A status report on RNAi therapeutics Open Access Review
... in a range of mammalian cells. Soon afterwards, it became clear that many different human cell types had endogenous machinery, the RNA-induced silencing complex (RISC), which could be harnessed to silence any gene in the genome. Beyond the availability of a novel way to dissect biology, an important ...
... in a range of mammalian cells. Soon afterwards, it became clear that many different human cell types had endogenous machinery, the RNA-induced silencing complex (RISC), which could be harnessed to silence any gene in the genome. Beyond the availability of a novel way to dissect biology, an important ...
Potentially Harmful Drugs in the Elderly: Beers List
... certain populations.1 New to the 2015 version is a list of potentially harmful drug-drug interactions in seniors, as well as a list of medications that may need to be avoided or their dosage reduced based on renal function.1 This information is not comprehensive; medications and interactions were ch ...
... certain populations.1 New to the 2015 version is a list of potentially harmful drug-drug interactions in seniors, as well as a list of medications that may need to be avoided or their dosage reduced based on renal function.1 This information is not comprehensive; medications and interactions were ch ...
Dabigatran - Developing Anaesthesia
... known as NOACs or “New Oral Anticoagulants”) which is an orally active direct Factor Xa inhibitor. It offers some significant therapeutic advantages over warfarin, but is more problematic with respect to its haemorrhagic complications. Most NOAC related bleeding occurs in the context of therapeutic ...
... known as NOACs or “New Oral Anticoagulants”) which is an orally active direct Factor Xa inhibitor. It offers some significant therapeutic advantages over warfarin, but is more problematic with respect to its haemorrhagic complications. Most NOAC related bleeding occurs in the context of therapeutic ...
Chemical-Principles-7th-Edition-Zumdahl-Test-Bank
... KEY: general chemistry | early atomic theory | atomic theory of matter | isotope 8. The element rhenium (Re) exists as two stable isotopes and 18 unstable isotopes. Rhenium-185 has in its nucleus A) 75 protons, 110 neutrons. B) 75 protons, 75 neutrons. C) 75 protons, 130 neutrons. D) 130 protons, 75 ...
... KEY: general chemistry | early atomic theory | atomic theory of matter | isotope 8. The element rhenium (Re) exists as two stable isotopes and 18 unstable isotopes. Rhenium-185 has in its nucleus A) 75 protons, 110 neutrons. B) 75 protons, 75 neutrons. C) 75 protons, 130 neutrons. D) 130 protons, 75 ...
Synthesis of novel dendrimers having aspartate grafts and their
... acidic drugs such as Nifedipine [10], Ibuprofen [11] and Indomethacin [12]. Further, PAMAM derivatives modified by –OH or –COOH groups were found to encapsulate small hydrophobic guest molecules successfully: Twyman et al. [13] converted the ester terminated PAMAM dendrimers to a more soluble hydroxy ...
... acidic drugs such as Nifedipine [10], Ibuprofen [11] and Indomethacin [12]. Further, PAMAM derivatives modified by –OH or –COOH groups were found to encapsulate small hydrophobic guest molecules successfully: Twyman et al. [13] converted the ester terminated PAMAM dendrimers to a more soluble hydroxy ...
World Health Organization Department of Communicable Disease Surveillance and Response WHO/CDS/CSR/DRS/2001.4
... spread of malaria to new areas and re-emergence of malaria in areas where the disease had been eradicated. Drug resistance has also played a significant role in the occurrence and severity of epidemics in some parts of the world. Population movement has introduced resistant parasites to areas previo ...
... spread of malaria to new areas and re-emergence of malaria in areas where the disease had been eradicated. Drug resistance has also played a significant role in the occurrence and severity of epidemics in some parts of the world. Population movement has introduced resistant parasites to areas previo ...
... Another way to look at consolidating testing is grouping tests based on platforms, according to Gibson from The Joint Commission. “We see an instrument as a single platform of testing—for example, a hematology analyzer or chemistry analyzer,” Gibson explained. “All of the tests that are being perfor ...
01 Chapter 1644 - Pharmaceutical Press
... As mentioned above, the solubility of an ionised therapeutic agent is a function of both the pKa of the compound and the pH of the formulation. Importantly, the acceptable pH range of solutions for oral administration is large, ranging from circa 5 to 8 pH units. Therefore, a common formulation stra ...
... As mentioned above, the solubility of an ionised therapeutic agent is a function of both the pKa of the compound and the pH of the formulation. Importantly, the acceptable pH range of solutions for oral administration is large, ranging from circa 5 to 8 pH units. Therefore, a common formulation stra ...
Beers Criteria Public Translation
... Why Experts Developed the Beers Criteria As you get older, your body changes. These changes can increase the chances that you’ll have side effects when you take medications. Older people usually have more health problems and take more medications than younger people. Because of this, they are also m ...
... Why Experts Developed the Beers Criteria As you get older, your body changes. These changes can increase the chances that you’ll have side effects when you take medications. Older people usually have more health problems and take more medications than younger people. Because of this, they are also m ...
AVEO and Astellas Announce Submission of New Drug Application
... results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: whether the results of TIVO-1 are sufficient to obtain marketing approval for tivozanib ...
... results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: whether the results of TIVO-1 are sufficient to obtain marketing approval for tivozanib ...
AGS Beers Criteria Summary for Patients and Caregivers.
... Why Experts Developed the Beers Criteria As you get older, your body changes. These changes can increase the chances that you’ll have side effects when you take medications. Older people usually have more health problems and take more medications than younger people. Because of this, they are also m ...
... Why Experts Developed the Beers Criteria As you get older, your body changes. These changes can increase the chances that you’ll have side effects when you take medications. Older people usually have more health problems and take more medications than younger people. Because of this, they are also m ...
Fluvoxamine as a cause of stimulation, mania and
... profile of fluoxetine and other SSRI’s). This stimulant continuum will be documented in many reports in the following review. 3.1. Confirmation of antidepressant-induced mania in the DSM-IV The American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition ( ...
... profile of fluoxetine and other SSRI’s). This stimulant continuum will be documented in many reports in the following review. 3.1. Confirmation of antidepressant-induced mania in the DSM-IV The American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition ( ...
Vincristine, Vincent Ting - UC Davis Department of Chemistry
... tw/ph/%B3B%A4%E8%B6%B0/drug/vincristine.files/image0 04.jpg) Vincristine can only be administered intravenously and if introduced into the spinal cord fluid, it ensures almost absolute death. Patients experience paresthesias because vincristine causes damage to small nerve fibers carrying the sensat ...
... tw/ph/%B3B%A4%E8%B6%B0/drug/vincristine.files/image0 04.jpg) Vincristine can only be administered intravenously and if introduced into the spinal cord fluid, it ensures almost absolute death. Patients experience paresthesias because vincristine causes damage to small nerve fibers carrying the sensat ...
幻灯片 1
... Safe degradation products Biocompatible High loading with ensured molecule efficacy High encapsulation Variable release profile Stable Inexpensive High quality ...
... Safe degradation products Biocompatible High loading with ensured molecule efficacy High encapsulation Variable release profile Stable Inexpensive High quality ...
4 Key Regulatory Guidelines for the Development of Biologics in the
... subject to licensure under the PHSA: vaccines; proteins, peptides, and carbohydrates produced by cell culture (other than hormones and products previously derived from human or animal tissue and approved as drugs); proteins made in transgenic animals; blood and blood products; and allergenic product ...
... subject to licensure under the PHSA: vaccines; proteins, peptides, and carbohydrates produced by cell culture (other than hormones and products previously derived from human or animal tissue and approved as drugs); proteins made in transgenic animals; blood and blood products; and allergenic product ...
Drug discovery
In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered through identifying the active ingredient from traditional remedies or by serendipitous discovery. Later chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology. Since sequencing of the human genome which allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for efficacy.Modern drug discovery involves the identification of screening hits, medicinal chemistry and optimization of those hits to increase the affinity, selectivity (to reduce the potential of side effects), efficacy/potency, metabolic stability (to increase the half-life), and oral bioavailability. Once a compound that fulfills all of these requirements has been identified, it will begin the process of drug development prior to clinical trials. One or more of these steps may, but not necessarily, involve computer-aided drug design. Modern drug discovery is thus usually a capital-intensive process that involves large investments by pharmaceutical industry corporations as well as national governments (who provide grants and loan guarantees). Despite advances in technology and understanding of biological systems, drug discovery is still a lengthy, ""expensive, difficult, and inefficient process"" with low rate of new therapeutic discovery. In 2010, the research and development cost of each new molecular entity (NME) was approximately US$1.8 billion. Drug discovery is done by pharmaceutical companies, with research assistance from universities. The ""final product"" of drug discovery is a patent on the potential drug. The drug requires very expensive Phase I, II and III clinical trials, and most of them fail. Small companies have a critical role, often then selling the rights to larger companies that have the resources to run the clinical trials.Discovering drugs that may be a commercial success, or a public health success, involves a complex interaction between investors, industry, academia, patent laws, regulatory exclusivity, marketing and the need to balance secrecy with communication. Meanwhile, for disorders whose rarity means that no large commercial success or public health effect can be expected, the orphan drug funding process ensures that people who experience those disorders can have some hope of pharmacotherapeutic advances.