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kutki churna - International Journal of Research in Ayurveda and
kutki churna - International Journal of Research in Ayurveda and

Product Information: Tiotropium bromide
Product Information: Tiotropium bromide

2. Basic Principles of Stability Testing
2. Basic Principles of Stability Testing

ENGLISH VERSION (Eng)
ENGLISH VERSION (Eng)

Preview Sample 2
Preview Sample 2

A New Approach to Drug Discovery and Development
A New Approach to Drug Discovery and Development

... new companies focused on this area, and the recent entry ...
- Journal of SOPI
- Journal of SOPI

... must consider the additional features of local and systemic issues, patient's economic status as well as potential adverse effect of the drug. There are large number of drug trial going on world wide to observe the effect of a particular drug or a molecule. However, the scenario has changed drastica ...
Department of Pharmacology
Department of Pharmacology

... mechanism of action, organ system effects – acetylcholine, betanechol, carbachol, cevimeline, pilocarpine). Basic pharmacology of the indirect-acting cholinomimetics (pharmacokinetics, mechanism of action, organ system effects – cholinesterase inhibitors). Therapeutic uses and toxicity of cholinomim ...
PPT here
PPT here

... in that particular tissue compared to normal tissue. 2. Prodrug level must be high enough to generate therapeutic levels of free drug in the target tissue. 3. Prodrug activation at the other sites must be minimal. 4. Prodrugs must be good substrate or possess high binding affinity for tissue associa ...
THE CONCEPT OF ESSENTIAL MEDICINES
THE CONCEPT OF ESSENTIAL MEDICINES

... This list is a dynamic list and revised every two years. The procedures for updating the List are in line with the WHO recommended process for developing clinical practice guidelines. Key components are a systematic approach to collecting and reviewing evidence and a transparent development process ...
Bioavailability The in
Bioavailability The in

... Some pharmaceutical equivalents or pharmaceutical alternatives may be equivalent in the extent of their absorption but not in the rate of absorption Therapeutic equivalents has been used to indicate pharmaceutical equivelents which when administered to the same individuals in the same dosage regi ...
酸枣仁油软胶囊的新药开发研究
酸枣仁油软胶囊的新药开发研究

... First killer:cardiac disease, 743,000 The cause Second killer:cancer, 529,000 of death Third killer:stroke, 150,000 Fourth killer:ADRs, 106,000 Fifth killer:drug abuse, 80,000 Vietnam war (10 AIDS≈road accident, 41,000 years):56,000 ...
Product Information: Tiotropium bromide
Product Information: Tiotropium bromide

... insufficiency is not expected to have any relevant influence on tiotropium pharmacokinetics. Tiotropium is predominantly cleared by renal elimination (74% in young healthy volunteers) and by simple non-enzymatic ester cleavage to products that do not bind to muscarinic receptors. ...
Reference Standards for
Reference Standards for

MYCOPHENOLATE MOFETIL for Connective Tissue Disease
MYCOPHENOLATE MOFETIL for Connective Tissue Disease

... http://howis.wales.nhs.uk/sitesplus/866/page/57539 Vaccination advice for patients with Autoimmune Inflammatory Rheumatic Disease is available for ABUHB Rheumatology at: http://howis.wales.nhs.uk/sitesplus/866/page/57540 ...
Attachment: Product Information: Levonorgestrel
Attachment: Product Information: Levonorgestrel

... 12 months after removal of the system. With Jaydess, the alterations in menstrual patterns are a result of the direct action of levonorgestrel on the endometrium and do not reflect the ovarian cycle. There is no clear difference in follicle development, ovulation or oestradiol and progesterone produ ...
SUMMARY OF DATA FOR CHEMICAL SELECTION
SUMMARY OF DATA FOR CHEMICAL SELECTION

... This problem first came to the attention of the National Cancer Institute’s (NCI) Division of Cancer Biology (DCB) when announcement of the availability of this new dietary supplement was made. Because the information submitted by the company addressed limited studies to show the safety of vincamine ...
In-Vitro-In-Vivo Correlation Definitions and Regulatory
In-Vitro-In-Vivo Correlation Definitions and Regulatory

... The general dissolution time point specification is ± 10% deviation from the mean dissolution profile obtained from the biobatch (1). Bioequivalency between formulations would be expected if the formulation(s) fall within the upper and lower limits of the specification. Dissolution specification set ...
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FOOD AND DRUG ADMINISTRATION, et al

... The ultimate issue in this case is whether Congress delegated to the Food and Drug Administration ("FDA"), through the Federal Food, Drug, and Cosmetic Act ("FDCA"), the authority to regulate tobacco products as drugs and devices. To sustain its claim to such authority, FDA must establish, inter ali ...
Dengue virus type 1 (ATCC® VR1586™)
Dengue virus type 1 (ATCC® VR1586™)

... lists the media formulation that has been found to be effective for this strain. While other, unspecified media may also produce satisfactory results, a change in media or the absence of an additive from the ATCC recommended media may affect recovery, growth and/or function of this strain. If an alt ...
Product Monograph - Ask Novartis Pharma
Product Monograph - Ask Novartis Pharma

... In a study of brinzolamide in lactating rats, decreases in body weight gain in offspring at an oral dose of 15 mg/kg/day (312 times the recommended human ophthalmic dose). Following oral administration of 14C-brinzolamide to lactating rats, radioactivity was found in milk at concentrations below tho ...
Raltegravir - Therapeutic Goods Administration (TGA)
Raltegravir - Therapeutic Goods Administration (TGA)

... tablets have considerably higher bioavailability at equal dose than the registered 400 mg conventional tablets. The peak plasma concentration (Cmax) and the area under the plasma concentration time curve (AUC) values of the chewable tablets are 3.22 and 1.78 times greater, respectively, than those o ...
Herbal / Drug Interactions PHARM 512: Clinical Applications of Drug
Herbal / Drug Interactions PHARM 512: Clinical Applications of Drug

... – Product selection: want standardized extract containing about 0.3% hypericin or 1-2% hyperforin – Dose: about 300mg TID for treatment – Questions remaining include • How best to use this herbal given that there are drug interaction problems ...
Pharmacokinetics
Pharmacokinetics

Ada_Dekhtyar
Ada_Dekhtyar

... drugs for use in the practice of obstetrics and gynecology) to be held on February 4 and 5, 1993, to discuss issues related to providing oral contraceptives without prescription.20 The issues scheduled for discussion at the Feb. 4-5 session were to include whether labeling can provide adequate inst ...
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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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