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Site-specific conjugation of a cytotoxic drug to an antibody improves
Site-specific conjugation of a cytotoxic drug to an antibody improves

... safety profiles8,20. In a study that underscored the consequences of this heterogeneity, researchers purified ADC fractions with exactly two, four or eight drugs attached to each antibody and compared these fractions for in vivo efficacy, tolerability in mice and pharmacokinetics8. The most heavily ...
Prodrugs—from Serendipity to Rational Design
Prodrugs—from Serendipity to Rational Design

... The latter are usually referred to as bioprecursor prodrugs. Conventional carrier-linked prodrugs often have a synthetic handle, a spacer or linker, between the active drug and the promoiety when the desired prodrug moiety cannot be attached directly to the parent molecule because of steric hindranc ...
THE TITLE: Pharmacokinetic Drug Interaction with Gemfibrozil
THE TITLE: Pharmacokinetic Drug Interaction with Gemfibrozil

... ratio of chromatogram peak area of drug versus internal standard. An aliquot of 20 µL containing volunteer plasma sample with internal standard was eluted at the flow rate of 1 ml/minute through the C18 stationary column and UV detection was done at 276 nm. The method was validated by determination ...
A comparative bioequivalence study of two prolonged
A comparative bioequivalence study of two prolonged

... Introduction. Extended release metoprolol formulations display a reduced rate of absorption and a more uniform release characterized by lower peaks, longer time to peak and smaller peak to trough variation, and this allows for convenient once daily administration. A major advantage of extended relea ...
Product Information for fluticasone propionate and azelastine
Product Information for fluticasone propionate and azelastine

... The efficacy of DYLASTINE 125/50 was established in four randomised, double-blind, placebo-controlled studies in subjects with seasonal allergic rhinitis (SAR), namely MP4001, MP4002, MP4004, and MP4006. Study MP4001 compared DYLASTINE 125/50 with commercial azelastine nasal spray (Astelin® Nasal Sp ...
Acetaminophen and Your Liver
Acetaminophen and Your Liver

... usually feels better. After 48-72 hours, however, liver enzyme (ALT and AST) levels start to rise, indicating liver injury. In the most severe cases, a person may develop acid buildup in the blood, excessive bleeding, and coma. At this stage, only a liver transplant can prevent death. Fortunately, t ...
PDF - World Journal of Pharmaceutical Sciences
PDF - World Journal of Pharmaceutical Sciences

... Ketorolac tromethamine is a potent non-steroidal drug with potent analgesic and anti-inflammatory activity. Its oral administration is associated with a high risk of adverse effects such as irritation, ulceration and bleeding of gastrointestinal tract. The present study focuses on the development of ...
Pharmacotherapy Treatment Options for Insomnia
Pharmacotherapy Treatment Options for Insomnia

... amnesia, complex sleep-related behaviors, and impaired balance with subsequent falls. As suggested above, the superiority of non-benzodiazepines over benzodiazepines have recently been questioned [31]. Although the 2005 NIH consensus conference [1] and a recent meta-analysis [32] supported a superio ...
VA Medicaid PDL Criteria (effective 01/01/2010)
VA Medicaid PDL Criteria (effective 01/01/2010)

... drugs, COX-2 inhibitors do not reduce the endogenous production of thromboxane A2, a potent platelet activator and aggregator, thereby causing a potentially prothrombotic cascade of events that could lead to a significant increase in the risk for thrombotic cardiovascular events (myocardial infarcti ...
Phebra Benztropine 2 mg in 2 mL Injection
Phebra Benztropine 2 mg in 2 mL Injection

... Mental confusion and excitement may occur with large doses, or in susceptible patients. Visual hallucinations have been reported occasionally. Furthermore, in the treatment of extrapyramidal symptoms due to central nervous system drugs, such as phenothiazines and reserpine, in patients with mental d ...
Safety of allopurinol compared with other urate
Safety of allopurinol compared with other urate

... has been performed following the Cochrane recommendations [11]. We first transformed the research question using the patient, intervention, comparator, and outcome (PICO) approach. A librarian developed the search strategy. The following electronic databases were searched: The Cochrane Library (2014 ...
Sample
Sample

... Incorrect Feedback: It was the amendment to The Food and Drugs Act of 1912 that ensured this, not the Food, Drug, and Cosmetic Act of 1938. d. stated that the government no longer needed proof of fraud to stop the sale of a drug Feedback: Correct! 10. In response to criticism related to the time lag ...
Memorandum bfAR 22  2oof
Memorandum bfAR 22 2oof

... Darmstadt, Germany, submits this new dietary ingredient notification to the Food and Drug Administration (“FDA”) for isoquercetin (quercetin-3-glocoside) to be manufactured by Merck. Merck’s isoquercetin product is intended for use as a dietary ingredient in dietary supplements. The product was crit ...
Expert Opin. Ther. Pat. 2016, 27, 179–189
Expert Opin. Ther. Pat. 2016, 27, 179–189

... Introduction: Drug conjugates are trend topics in Chemical Biology. These entities are an emerging class of highly potent biopharmaceutical drugs, best known in the field of oncology, that have been also designed as a targeted therapy/diagnosis for the treatment/prevention of several bacterial disea ...
product monograph serc
product monograph serc



... complex, expensive, and time-consuming threestep liquid–liquid extraction which requires more sophisticated equipment (13). These methods are time-consuming; therefore, they are cumbersome for bioavailability and bioequivalence studies. The pharmacokinetics of clomipramine has been documented elsewh ...
Erasmus Partner Universities of Ankara University Faculty of
Erasmus Partner Universities of Ankara University Faculty of

... The International Esenboga Airport is 30 km north of the city center. Transportation is provided by HAVAS shuttle buses with a reasonable fare to the city centre. Most of the airlines only flies to Atatürk Airport or Sabiha Gökçen Airport, which are in İstanbul. So you have to transfer to another ve ...
Clinical Implications of Dihydropyrimidine
Clinical Implications of Dihydropyrimidine

... DPD enzyme activity in normal tissues (peripheral blood mononuclear cells and liver) has also been shown to vary from individual to individual in a normal distribution pattern, with as much as a sixfold variation from the lowest to the highest values.[8,9] This wide variation in DPD activity is thou ...
Prescription Drug Cost Sharing - Associations With Medication and
Prescription Drug Cost Sharing - Associations With Medication and

... of Medicare ⫹ Choice plans that covered branded drugs had an annual dollar cap ranging from $750 to $2000 per year.4 Analogous policies used by state Medicaid programs place limits on the number of prescriptions dispensed per patient per month. Because benefit caps represent an extreme version of co ...
DMID 01-553 FQ EBA Study Results
DMID 01-553 FQ EBA Study Results

... drugs; rate determined by bacterial metabolism & rapidity of action of drug(s) ...
Express Scripts 2015 Drug Trend Report Workers` Compensation
Express Scripts 2015 Drug Trend Report Workers` Compensation

... consultative tools and predictive analytics, like the morphine equivalent dose (MED) point-of-sale program, physician outreach programs and patient narcotic education. These resources allow us to flag situations that could indicate abuse or misuse, whether in the actions of physicians, pharmacies or ...
Basics Pharmacology Review - Dr. Roland Halil
Basics Pharmacology Review - Dr. Roland Halil

... Pharmacist, Bruyere Academic FHT Assistant Professor, Dept Family Medicine, U of Ottawa March 2015 ...
english, pdf
english, pdf

... Also, to give a new lease of life to a patented product whose patent term is about to expire, the formulation and development of the drug into a new dosage form like ODT allows pharmaceutical companies to enjoy market exclusivity (9). Formulation of ODT has been studied as one of the ways to improve ...
AGNP Consensus Guidelines for Therapeutic Drug Monitoring in
AGNP Consensus Guidelines for Therapeutic Drug Monitoring in

... Therefore, after having focused clinical research on the development of new drugs during more ...
AGNP Consensus Guidelines for Therapeutic Drug Monitoring in
AGNP Consensus Guidelines for Therapeutic Drug Monitoring in

... The benefits of TDM regarding the optimization of pharmacotherapy, however, can only be obtained if the method is adequately integrated into the clinical treatment process. Current TDM use in psychiatric care is obviously suboptimal [134, 700, 742]. Similar to other medical disciplines, systematic s ...
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Biosimilar

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is a copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original ""innovator"" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product.Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; animal studies (including the assessment of toxicity); and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently, EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar filgrastim Zarxio.
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