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Basic Principles of GMP
Basic Principles of GMP

... used in accordance with their label and with conventional DF, not at all specifically adapted to the children use.  The dose of API is fixed by using empirically established dosage regimen and the dose combination is sometimes largely used, which is not really convenient.  The DF used and the ones ...
Stevens Johnson Syndrome
Stevens Johnson Syndrome

... characteristics of the patient experiencing the reaction, the diagnosis Case-control study. The international case-control study was designed to (according to the reporter and coded by a standard system), the type of reactions (up to 4 per case), the drugs and biologics to which the patient was esti ...
P-glycoprotein and chiral antidepressant drugs: Louise Karlsson Pharmacokinetic, pharmacogenetic and toxicological aspects
P-glycoprotein and chiral antidepressant drugs: Louise Karlsson Pharmacokinetic, pharmacogenetic and toxicological aspects

... regarding the very variable individual responses to treatment have been focused on in recent years. Despite the fact that psychoactive drugs are widely used in psychiatry, limited knowledge about the actual effects and turnover in the body is available. This is of particular importance for antidepre ...
rash remedy document - Poison ivy roots dug out ...by The Gloved
rash remedy document - Poison ivy roots dug out ...by The Gloved

Fast Dissolving Tablets- A Novel Approach
Fast Dissolving Tablets- A Novel Approach

... “zydis unit” during freeze drying process or long term storage glycine is generally used as collapse protectants. To protect the formulation from the moisture it should be packed in a blister[27] 6.2 Durasolv Technology It is patented technology of CIMA LAB(US patent no.6,024,981) and is based on di ...
Inconspicuous and Miscalculated Opioid Risks
Inconspicuous and Miscalculated Opioid Risks

The pharmacokinetic profile of fesoterodine
The pharmacokinetic profile of fesoterodine

Paracetamol and Ibuprofen for Paediatric Pain and Fever
Paracetamol and Ibuprofen for Paediatric Pain and Fever

... In general, caution should be exercised with paediatric dosing, as their is potential for dramatic variability in drug levels depending on the neonate’s age. At six months of age, the neonate’s renal clearance is almost twice that of adults, while in premature infants clearance can be impaired by 50 ...
The value of computer-administered self
The value of computer-administered self

... versions. No significant difference between mean HAMA scores obtained by computer or clinician was observed among the patients diagnosed with anxiety disorders, although a small significant difference in total scores was detected for the sample overall, which was not clinically relevant as it was wi ...
KINETIC STUDY OF THE IN VITRO RELEASE AND STABILITY OF... FLOATING BEADS Research Article
KINETIC STUDY OF THE IN VITRO RELEASE AND STABILITY OF... FLOATING BEADS Research Article

... Theophylline floating beads have been investigated as a possible gastro-retentive dosage forms. Emulsion gelation method was used in the preparation of oil entrapped floating alginate beads. Drug content and floating properties of the prepared beads were determined. The data obtained from the in vit ...
- The University of Liverpool Repository
- The University of Liverpool Repository

... as the target of F901318 and despite the presence of a mammalian version of the enzyme, no target-based toxicity was predicted. Upon elucidation of the mechanism of action, the F3-series was renamed the orotomides combining the mechanism (dihydroorotate) with the chemistry (αketoamide). Further enz ...
drugs and cosmetics (iind amendment) rules, 2005
drugs and cosmetics (iind amendment) rules, 2005

drug registration guidance document
drug registration guidance document

Quantitative Structure-Activity Relationship Modeling to Predict Drug-Drug Interactions
Quantitative Structure-Activity Relationship Modeling to Predict Drug-Drug Interactions

... The evaluation of drug-drug interactions (DDI) is a crucial step in pharmaceutical drug discovery and design. Unfortunately, if adverse effects are to occur between the co-administration of two or more drugs, they are often difficult to test for. Traditional methods rely on in vitro studies as a bas ...
NTP Botanical Dietary Supplements Program
NTP Botanical Dietary Supplements Program

... of supplements, and may lead to removal of unsafe products from the market. How does NTP evaluate botanical dietary supplements? Researching the potential adverse effects of botanical dietary supplements presents several unique challenges. For example, many supplements contain a complex mixture of i ...
International Journal of Pharmacy
International Journal of Pharmacy

Naturopathy Act, 2007 - O. Reg. 168/15
Naturopathy Act, 2007 - O. Reg. 168/15

... 1. The member must have a naturopath-patient relationship with the patient for whom the drug is prescribed. 2. The member must prescribe the drug for therapeutic purposes only. 3. The member must possess sufficient knowledge, skill and judgment respecting the drug and the patient’s condition to pres ...
Memorandum JAN 2 3
Memorandum JAN 2 3

... identified as: Neptune Krill OilTM(Krill oil), Neptune AquaGneTM (&ill-based protein concentrate powder of the dry residue from the extraction of ttil), and Neptune LyO-Krillw (freeze-dried Bill). YOU indicated that the primary source OI all three ingredients is Krill, a shrimp-like crustaceanidenti ...
System-Wide Medication Related Decision Evaluation
System-Wide Medication Related Decision Evaluation

...  An FDA alert released in August 2012 warned about the risk of respiratory depression and death in pediatric patients receiving codeine for post-tonsillectomy and adenoidectomy pain management.2  In 2013, the FDA updated recommendations and added a black box warning and contraindication for use of ...
SUMMARY OF PRODUCT CHARACTERISTICS 1
SUMMARY OF PRODUCT CHARACTERISTICS 1

... rabbit eyes. The formulation produced no observable effects in rabbits after dermal application of 13 mg /kg for 90 days. No compound-related dermal or systemic effects were observed in a 13-week cutaneous route toxicity study, in which Rozex gel containing Metronidazole 0.75% w/w was applied daily ...
Recommendations for TDM - Auburn University College of
Recommendations for TDM - Auburn University College of

... Testing: At least 50% of cyclosporine in blood is in the red blood cell. As such, whole blood should be submitted. Cyclosporine is metabolized to over 14 different compounds with variable activity. HPLC provides the most accurate method of measuring the parent compound but does not measure any activ ...
Product information for strontium ranelate
Product information for strontium ranelate

... studies program of PROTOS was made up of two international randomised placebocontrolled phase III studies: the Spinal Osteoporosis Therapeutic Intervention (SOTI) study and the Treatment of Peripheral Osteoporosis (TROPOS) study. In addition to their treatment (2g/day strontium ranelate or placebo), ...
Product information for strontium ranelate
Product information for strontium ranelate

D I NEW DRUGS - Ontario Pharmacists Association
D I NEW DRUGS - Ontario Pharmacists Association

... In the study by Smith et al.,12 it is of note that the primary efficacy variable—difference in mean ambulatory blood pressure during the 10 to 16 hour post-dose period—was selected based on previous pharmacokinetic studies that demonstrated significant differences in diltiazem concentrations between ...
priority medicines for children
priority medicines for children

... there have been examples of low-uptake levels of novel solid formulations, due to their high cost implications, or common unfamiliarity with new formulations. Thus, patient and health care professionals' education about novel formulations, and evidence-based research on added value for children (i.e ...
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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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