Drug Products
Considerations and recommendations on traditional and non-traditional uses of excipients in oral drug products
... in drug products independently of the route of administration where both traditional and non-traditional uses are ...improved drug absorption and pharmacokinetics include their ability to modulate ...
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FORCED DEGRADATION STUDIES: PRACTICAL APPROACH - OVERVIEW OF REGULATORY GUIDANCE AND LITERATURE FOR THE DRUG PRODUCTS AND DRUG SUBSTANCES
... of drug substances and drug ...degradation products formed during forced degradation studies may not actually be observed to form during stability studies, in which case they need not be examined ...
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Development and Validation of an HPLC Method for the Analysis of Sirolimus in Drug Products
... the drug in analytical solution was checked by replicate analysis (N = 3) of the three control samples (in low, medium and high concentrations) for 6 h (considering the approximate time required for preparation of ...
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TECHNICAL STEPS AND CHALLENGING DECISIONS DURING REGISTRATION OF DRUG PRODUCTS
... A format for submission of clinical evidence for systematic evidence-based reviews of drug classes. The standard protocol for submission of dossier is studied. Evidence submissions prepared under this protocol are ...
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Solid state characterization of atorvastatin in drug products
... Two Atorvastatin marketed products with different composition and showing significant discrepancy in dissolution kinetics were subjected to solid state characterization. PXRD, DSC and FTIR didn’t show any ...
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Dosage strength is associated with medication persistence with Ginkgo biloba drug products: a cohort study of ambulatory drug claims data in Germany
... (different drug product and/or different dosage strength) after the index prescription was permitted and was not regarded as treatment ...any drug in the data- base) or at the end of the study period (12 ...
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PRODUCT DEVELOPMENT OF OPHTHALMIC ALPHA 2 ADRENERGIC AGONIST SOLUTION
... Light stability: The international conference of harmonization (ICH) gives out a guideline for conducting photostability tests on new pharmaceutical drug substances. [15] The Light stability study was carried out ...
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ICH guidelines – “Q” series (quality guidelines) - A review
... in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as impurities ...the drug product should be controlled ...
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INNOVATIVE AND NOVEL STRATEGY: MICROSPONGES FOR TOPICAL DRUG DELIVERY
... of drug delivery is the latest technology which has been introduced in topical skin care, drug products to facilitate the controlled release of the active medicament into the skin in order to reduce ...
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CURRENT TRENDS IN PULSATILE DRUG DELIVERY SYSTEMS
... Pulsatile Drug Delivery System: The development of drug products by pulsatile technology is very challenging since it requires the correct dose to reach the right site at the appropriate ...
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Mercury determination in drug and cosmetic products
... Several analytical techniques and methods are used for the determination of mercury in different samples and matrices, that provide a high selectivity and precision, like spectrophotometric methods. (Rathje 1969), AAS ...
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A Study on Evaluating Prescriptions in Emergency Unit of Tertiary Care Teaching Hospital Based on Who Prescribing Indicator
... prescribing. There may be multiple reasons for this; physician prefers to write brand names of drugs of repute rather than by generic names though there are no differences in efficacy, safety and quality and also due to ...
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Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations
... liposomal drug products, followed by metal colloids and block copolymer ...and drug product, a case-by-case or product class-specific approach for evaluation and regulation seems to be ...
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Formulation and Evaluation of Indomethacin Extended Release Pellets.
... oral drug products, such as tablets and capsules, are formulated to release the active drug immediately after oral administration, to obtain rapid and complete systemic drug ...release ...
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A NEW ERA IN TOPICAL FORMULATIONS – MICROSPONGE DRUG DELIVERY SYSTEM
... specific drug delivery ...microsponge drug delivery ...topical drug products to increase the controlled release of active drug into the skin in order to reduce entry of drug in ...
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Shifting Paradigms Revisited: Biotechnology and the Pharmaceutical Sciences
... protein drug substances and drug products have become available, 51 we still do not have reliable tools that accurately predict the incidence and d more importan- tly d clinical relevance of the ...
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Download Download PDF
... of drug sub- stances into drug products, while differences in solubili- ty may have implications on the absorption of the active drug from its dosage form, by affecting the dissolution rate ...
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PHARMACEUTICAL ASSESSMENT OF FIVE DIFFERENT GENERIC BRANDS OF PREDNISOLONE TABLETS IN LIBYAN MARKET
... generic drug products from different multiple sources has placed people and prescribers in a position of selecting one from among several seemingly equivalent ...these products are inexpensive and ...
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STABILITY STUDY OF LIQUID PARAFFIN ORAL EMULSION (CREMAFFIN)
... The storage conditions to be selected are based upon the climatic zone in which the product is intended to be marketed or for which the product is proposed to be filed for regulatory approval. General recommendations on ...
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Acute adverse events from over the counter Chinese herbal medicines: a population based survey of Hong Kong Chinese
... adverse drug event ...adverse drug reactions includes many items which may be quite mild (such as minor skin irri- tation), the clinical significance of these adverse events is unknown and represents a ...
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