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drug registration guidance document
drug registration guidance document

... morbidity and death when used throughout pregnancy’ under 1. ACE INHIBITOR Appendix 6 : Addition of PERGOLIDE & PHENYLPROPANOLAMINE in the List of ingredients (active) not allowed to be registered by the Drug Control Authority Appendix 11 : Guidance specific for OTC External Personal Care Products D ...
Cytochrome P450 Inhibition
Cytochrome P450 Inhibition

LINUS PAULING: CRANK OR GENIUS?(Accuracy in Media 1994
LINUS PAULING: CRANK OR GENIUS?(Accuracy in Media 1994

... Grouping the papers together for maximum attention, authors Linus Pauling and Robert Corey must have realized the bombshell they had dropped on the scientific world. Knowledge of the inner workings of proteins--molecules often referred to as the building blocks of life--would be the key to understan ...
Universidade de Lisboa Faculdade de Farmácia Assessing drug
Universidade de Lisboa Faculdade de Farmácia Assessing drug

... national compendium reported the British National Formulary as the most commonly used compendium. When assessing Summaries of Product Characteristics (SmPCs), we found that their content on clinical pharmacology information is insufficient. Information on this topic was found to be very similar to t ...
DXM
DXM

... •  Majority of respondents (79%) reported using DXM to explore their consciousness or alter their state of mind.! •  While many respondents mentioned DXM’s accessibility (legal, readily available, cheap) as a reason or benefit of using DXM, the focus was on specific effects, such as dissociation and ...
development, characterisation and evaluation of sildenafil aspirin co
development, characterisation and evaluation of sildenafil aspirin co

... Cocrystals are structurally homogeneous crystalline materials containing two or more components present in the definite stoichiometric amounts. Pharmaceutical Co-crystals are the nonionic supra molecular complexes and can be used to address the physical property issues such as solubility, stability ...
Drug-Induced Lupus Erythematosus
Drug-Induced Lupus Erythematosus

... The risk classification system applied to traditional drug-induced lupus has not yet been extended to include the newer biological modulators. This is primarily due to difficulty in establishing criteria for the diagnosis of druginduced lupus in patients placed on these drugs whom, in all likelihood ...
Routine analysis of amphetamine class drugs as their
Routine analysis of amphetamine class drugs as their

... of GC–MS for confirmation and identification of amphetamines in urine is often restricted by cost and expertise. A significant number of clinical laboratories in the EU use commercial TLC systems for the confirmation and identification of amphetamines in immunoassay positive urines [7]. TLC is both ...
2013 Pharmacist Liability
2013 Pharmacist Liability

... - Mnemonic, Sig or speed codes – Abbreviations that represent the name and dosage of a drug, and which can be rapidly entered into a pharmacy computer. ...
Technical Guide for countries to set targets for universal
Technical Guide for countries to set targets for universal

... as prisons. It is important to define the scope of the areas or settings under consideration. While this Technical guide focuses primarily on IDUs, it may also be useful for setting targets for HIV interventions targeting problematic drug users who do not inject but who are at risk of starting to do ...
Boerhaavia diffusa roots - Sri Sri Ayurveda Sri Sri Ayurveda
Boerhaavia diffusa roots - Sri Sri Ayurveda Sri Sri Ayurveda

... profile and in vitro antioxidant and anti acetylcholinesterase activities are described for the first time, providing further knowledge on this species’ chemistry and biological potential.33 2.4.2 Ethanol and methanol extracts were prepared and screened for in-vitro antioxidant activities using Ferr ...
5-Fluorouracil encapsulated alginate beads for the treatment of
5-Fluorouracil encapsulated alginate beads for the treatment of

... in size. Irregularly shaped small beads were observed when lower drug loads of less than 5% (w/v) were used. As the drug-load was increased, larger beads were obtained, in which the resultant beads contained higher 5-FU content. When less 5-FU was introduced, the dispersion of the 5-FU into gels by ...
July 28, 2014 Margaret A. Hamburg, MD
July 28, 2014 Margaret A. Hamburg, MD

... Public Citizen, a consumer advocacy organization with more than 300,000 members and supporters nationwide, hereby petitions the Food and Drug Administration (FDA), pursuant to the Federal Food, Drug, and Cosmetic Act 21 U.S.C. § 352 and 21 C.F.R. §§ 10.30 and 330.10(a)(7)(v), to immediately take the ...
wiley_ch6_Chemical_Equilibrium
wiley_ch6_Chemical_Equilibrium

...  Initially forward reaction rapid  As some reacts [N2O4] so rate forward  ...
Hard gelatin capsules today – and tomorrow
Hard gelatin capsules today – and tomorrow

... dosage form for liquid balsam copaivae, which had been used during the Napoleonic wars as a cure for vascular diseases. This was of great importance, as the substance causes severe nausea if taken as an oral ...
Antipsychotic Medication
Antipsychotic Medication

... Mosby items and derived items © 2009 by Mosby, Inc., an affiliate of Elsevier Inc. ...
G6PD deficiency: a classic example of pharmacogenetics with
G6PD deficiency: a classic example of pharmacogenetics with

... favism (Sansone & Segni, 1958), an acute syndrome associated with anaemia, haemoglobinuria and jaundice, potentially fatal especially in children, intriguingly affecting only some of the many people who eat fava beans. Favism had been known for centuries (Fermi & Martinetti, 1905), but it had been m ...
Cytochrome P4502C9: an enzyme of major importance in human
Cytochrome P4502C9: an enzyme of major importance in human

... that the ability of CYP2C9 and closely related isoforms to metabolise a particular substrate or group of compounds may be defined by a few critical residues or even a single amino acid within an SRS. For example, the Ile359Leu substitution in SRS5 of CYP2C9 markedly decreases the hydroxylation of to ...
The following information was generated from the Hazardous
The following information was generated from the Hazardous

... chloride, potassium, and inorganic phosphates has also occurred in patients receiving the drug. [McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 2953]**PEER REVIEWED** Hepat ...
Neomycin - Australian Pesticides and Veterinary Medicines Authority
Neomycin - Australian Pesticides and Veterinary Medicines Authority

... neomycin has a similar mechanism of action to gentamycin, so the information on aminoglycoside toxicity in general will be included in this assessment and any research that was generated using neomycin will be specifically highlighted as such. Unless indicated otherwise, the cited information has be ...
Misleading score-lines on tablets: facilitated
Misleading score-lines on tablets: facilitated

... Approximately a quarter of the tablets are split by patients in ambulatory settings [1, 2] and about 12% of the drugs prescribed at hospital discharge are in split form [3]. The pros and cons of splitting tablets are well known: dose flexibility (e.g., for paediatric or geriatric patients, in the ca ...
BENZOX AC BAR PRESCRIBING INFORMATION Benzoyl Peroxide
BENZOX AC BAR PRESCRIBING INFORMATION Benzoyl Peroxide

... contact with hair, fabrics or carpeting as benzoyl peroxide will cause bleaching. Carcinogenesis, Mutagenesis, Impairment of Fertility — Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to c ...
Photo-oxidation of pinonaldehyde at low NOx
Photo-oxidation of pinonaldehyde at low NOx

... chemistry of pinonaldehyde and similar compounds in the literature (Glasius et al., 1997). Though we recently described SOA chemistry under highNOx conditions (Chacon-Madrid and Donahue, 2011), it is important to explore its chemistry in low-NOx conditions because products of biogenic species are co ...
Appropriate Use of Drug Testing in Clinical Addiction Medicine
Appropriate Use of Drug Testing in Clinical Addiction Medicine

... procedures that are recommended by ASAM. The White Paper provided extensive background regarding the science and current practices of drug testing in various contexts, as well as broad suggestions for ways to improve drug testing in clinical practice. However, the White Paper acknowledged that more ...
ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION FOR THE ESTIMATION
ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION FOR THE ESTIMATION

... and accurate and can thereby easily adopted for routine quality control analysis. The results of this analysis confirmed that the proposed method was suitable for determination of drug in pharmaceutical formulation with virtually no interference of additives. Hence the proposed method can be success ...
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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.
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