Tartrazine: a potentially hazardous dye in Canadian drugs.
... soaps, may all contain tartrazine. Pharmaceutical manufacturers use this dye in many types of drug products. Tablets
and capsules may contain tartrazine in coatings, shells and
excipient materials.8 Other dosage forms in which tartrazine
may be found include liquids for ingestion, lozenges, ointment ...
Pharmacokinetic and pharmacodynamic drug interactions
... in vivo studies investigating such interactions were identified
by searches using databases such as MEDLINE, EMBASE,
BIOSIS, Australasian medical index (AMI) and international
pharmaceutical abstracts. Search terms were kava, kawa,
Piper methysticum, kavalactones, kava–drug and kava–herb
Synthesis and in vitro activities of a new antiviral duplex drug linking
... for new effective antiviral agents is ongoing.1,2 The successful clinical application of new antiviral drugs, however, is often limited as
compounds with high in vitro activity do not meet the high expectations made for drug development and licensing. An alternative to
the search for new single agen ...
Safety Assessment Of Alumina And Aluminum Hydroxide As Used
... The Panel also concluded that the aluminum hydroxide used in cosmetics is chemically equivalent to that used in
OTC antacid products. The FDA found that the information submitted for the approval of those drugs was adequate to
support safe use. The FDA also determined that aluminum hydroxide is gene ...
Ropinirole 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg
... Synthesis of the active substance from the designated starting materials has been
adequately described and appropriate in-process controls and intermediate
specifications are applied. Satisfactory specifications are in place for all starting
materials and reagents and these are supported by relevant ...
Allergan to Acquire Naurex - McCormick School of Engineering
... decade, according to NeuroPerspective, a newsletter. This year so far, $4.3 billion has already been put into such
firms, not including this deal. Among the beneficiaries have been neuroscience-based companies like Sage
Therapeutics and Intracellular therapies.
Discussions for the deal began late la ...
... recognise many epileptic diseases or syndromes and each of them can be expressed clinically by one or
several seizure groupings. Partial epilepsies (localisation related) are the more frequent, accounting for
more than 60% of the epilepsies, and they include most of the difficult-to-treat patients. ...
Assessment report on hamamelis virginiana l - EMA
... America, found in damp woods ranging from Nova Scotia to Florida and as far west as Texas. It is
cultivated on a small scale in Europe, though the material of commerce is obtained mainly from the
eastern USA and Canada (Wichtl and Bisset, 1994).
The flowers, bark and leaves of the common, colourful ...
2009 St Johns Wort Quality Issues and Active Compounds
... Nielsen et al. and Baureithel et al. focused their investigations on the bifl avone
amento-fl avone, which bound to the brain benzodiazepine receptors with an affi nity
comparable to diazepam (18, 19). However, the fl avonoids rutin, hyperoside, and
quercitrin did not inhibit benzodiazepine binding ...
Final Amended Safety Assessment of Sodium Sulfate as Used in
... VCRP data obtained from the FDA in 2016 indicate that Sodium Sulfate is used in 777 cosmetic formulations6
compared to 28 uses in the 2000 assessment1 (Table 1). Frequencies of use notably increased since 2000 as follows
(uses reported in 20166 vs. uses reported in 20001): 86 vs. 13 leave-on; 661 vs ...
5 1 Prereview - World Health Organization
... Lisdexamfetamine is a prodrug and an inactive molecule until ingestion. After oral
administration, enzyme hydrolysis following contact with red blood cells will break
lisdexamfetamine into L-lysine, a naturally occurring essential amino acid and active damphetamine which is responsible for the drug’ ...
Evaluation of the use of static and dynamic models to predict drug
... extraction and neglecting gut extraction in the case of induction interactions, performed better
than Simcyp (84% compared to 58% of the interactions predicted within 2-fold). Differences in
the prediction outcomes between the static and dynamic models are attributable to differences
in first-pass c ...
PRODUCT MONOGRAPH PrMONUROL® Fosfomycin powder, 3g
... MONUROL to fasted patients, the total body clearance (CLBT) and mean renal clearance (CLR) of
fosfomycin are 16.9 L/hr and 6.3 L/hr respectively. Approximately 38% of a MONUROL dose
(equivalent to 3 g of fosfomycin) is recovered from urine and 18% is recovered from feces.
A mean maximum urine fosfom ...
PropoFlo - zoetisUS.com
... source of exposure and seek medical attention. Respiratory
depression should be treated by artificial ventilation and oxygen.
... glass throat were used to determine these distributions.
The QCM provided nearly real-time distributions for the
mass and radiolabel on the day of the study. The Andersen
samplers provided drug and radiolabel distributions at a
later date for verification. Before the labelling procedure
began, the c ...
Safety Assessment Of Alumina And Aluminum Hydroxide As Used
... Definitions, CAS Nos., and functions are provided in Table 1. The structures of alumina and aluminum hydroxide
are provided in Figure 1.
Alumina, also known as aluminum oxide (Al 2 O 3 ), is dehydrated (or calcined) aluminum hydroxide.1 Alumina is
also the primary constituent of emerald, ruby, and s ...
Minutes of 246th meeting of Registration Board
... Director QA < opined that for export purpose only those formulations should be
registered, which are already registered in Pakistan. For new fornulations (which are not
registered in Pakistan), manufacturers should first conduct stability studies and then
registration for export purpose be granted ...
Codeine use in children and ultra-rapid metabolisers
... products in Australia. This is in contrast to other major jurisdictions including the United States,
European Union and Canada. Codeine is a commonly used medication that may be perceived by
the Australian public to be very safe, especially in light of its availability in OTC preparations.
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.