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the Patheon OneSource™ Information Sheet
the Patheon OneSource™ Information Sheet

... bb One contract for clarity and a rapid project start. bb One point of contact for efficient communication and coordination. bb One integrated supplier to put hours back into your workday. Experience – Maximize value with a partner trusted by the industry. bb 450+ clients, ranging from large pharma ...
The Australian Clinical Trial Handbook
The Australian Clinical Trial Handbook

... These comprise the so-called principles of “Good Clinical Practice” or GCP. Although the methods for implementing and enforcing these principles vary across regulatory agencies, the end result, it is hoped, are trials that collect high quality, credible data that contribute to the answering of speci ...
Thyroxine Sodium - Therapeutic Goods Administration
Thyroxine Sodium - Therapeutic Goods Administration

... processing; and it can be prone to instability. Historically, these known problems have led to concerns about variations in effectiveness and stability; within and across branded products, even before the introduction of generics. A recent Medicines and Healthcare Products Regulatory Agency (MHRA) r ...
Asthma Technology
Asthma Technology

sustained release matrix type drug delivery system: a review
sustained release matrix type drug delivery system: a review

Australian public assessment for Thyroxine Sodium
Australian public assessment for Thyroxine Sodium

... Stability data were generated under accelerated and long-term conditions on batches packaged in the proposed container closure system (which includes a child-resistant closure). This would support a shelf life of 2 years when stored below 25ºC with the condition protect from light. The tablets are m ...
AusPAR: Emtricitabine / rilpivirine / tenofovir disoproxil fumarate
AusPAR: Emtricitabine / rilpivirine / tenofovir disoproxil fumarate

Protocol S1.
Protocol S1.

Clinical Relevance of Drug Releases Testing
Clinical Relevance of Drug Releases Testing

... an excellent research tool. … Products with poor dissolution characteristics are obviously poor candidates for the market place or for clinical trials. … Unfortunately, the converse is not always true. … Laboratory tricks whose sole purpose is to increase the rate of solution are … not always a guar ...
Main title slide header
Main title slide header

... Sources: Citeline, Express Scripts,2013, Drug Trend Report; IMS Health Report, 2014; JPM Healthcare Technology Report, 2013; Wells Fargo Report, 2013, PwC Specialty drug report, Fierce Biotech, DCAT, Cowen – Therapeutic Categories Outlook (Feb 2015), Strategy& analysis ...
10k
10k

... with drugs of this class, the most frequent of which is fatigue. Pracinostat has demonstrated clinical evidence of single-agent activity in patients with AML and myelofibrosis. In a Phase I dose-escalation trial in patients with advanced hematologic malignancies, 14% of evaluable patients (two out o ...
Breathe in, Breathe out, How to Pick `em Out: Selecting Inhalers for
Breathe in, Breathe out, How to Pick `em Out: Selecting Inhalers for

... albuterol vs PRN albuterol – No difference in level of asthma control – No difference in efficacy or side effects ...
GP at 6 months in between specialist reviews
GP at 6 months in between specialist reviews

... Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged from 6 years up to but not including 18 years of age. This shared care guideline relates to patients with ADHD whose condition is stable at hand over from the ADHD Specialist (Paediatrics/CAMHS) to primary ...
Buccal Drug Delivery Systems: Opportunities And Challenges In Buccal,
Buccal Drug Delivery Systems: Opportunities And Challenges In Buccal,

... totalled approximately $1.3 billion in the U.S. while the total market grew to more than $1.7 billion, driven by a 11 percent increase in prescriptions. In 2014, Bunavail buccal film has received US approval which has similar bioavailability of suboxone with half of the dose of buprenorphine. Other ...
Latest data on management of bleeding in patients taking DOACs
Latest data on management of bleeding in patients taking DOACs

... Apixaban 5 mg bd, for four days then randomized in a 2:1 ratio to receive either andexanet alfa administered as an 800 mg IV bolus followed by a continuous infusion of 8 mg/min for 120 minutes or to placebo. ...
Review of ADHD Pharmacotherapies: Advantages, Disadvantages, and Clinical Pearls
Review of ADHD Pharmacotherapies: Advantages, Disadvantages, and Clinical Pearls

... preparations dosed multiple times per day. Data demonstrating the efficacy of these stimulant medications for the treatment of ADHD and their role in treating children was well established by the 1970s. Multiple formulations of the stimulant medications have subsequently been developed during the pa ...
Margolin
Margolin

... and institutions; and it must live with itself—which societies no less than individuals must be able to do—in the wee hours of the morning when it must realize that it savagely persecutes pushers, who like the abortionists of such recent past, merely offer a product or service for which there is an ...
IN VITRO Research Article SAKTHIVEL M*
IN VITRO Research Article SAKTHIVEL M*

... After the removal of unentrapped drug by dialysis, the entrapment efficiency of all the formulations was studied. The various factors like lipid concentration, drug to lipid ratio and cholesterol content may change the entrapment efficiency. From this study, it was found that the entrapment efficien ...
KPGA Formulary Update August 2012
KPGA Formulary Update August 2012

Heparin, low-molecular–weight heparins, and heparin - hem
Heparin, low-molecular–weight heparins, and heparin - hem

... LMWHs are now globally regarded as drugs of choice for surgical prophylaxis of DVT and the management of acute coronary syndromes. Recently, these agents were also approved for the treatment of thrombotic disorders. Several products are available for clinical use worldwide. Because of manufacturing ...
Evaluation for Zero-order Controlled Release Preparations of
Evaluation for Zero-order Controlled Release Preparations of

ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES AND
ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES AND

... incorporation of cholesterol or their lipids. They are vesicular systems similar to liposomes that can be used as carriers of amphiphilic and lipophilic drugs. Noisome are promising vehicle for drug delivery and being non-ionic; and Niosomes are biodegradable, biocompatible nonimmunogenic and exhibi ...
RSI for Reporting Period
RSI for Reporting Period

... This section should provide a brief narrative overview including: date of first approval, indication(s), approved dose(s), and where approved, if applicable. has a Marketing Authorisation, but the University of Keele are not the MA holder and therefore the are not aware of ...
Toxicologic Pathology - Ocular Therapeutix, Inc.
Toxicologic Pathology - Ocular Therapeutix, Inc.

Extralabel use of ivermectin and moxidectin in food animals
Extralabel use of ivermectin and moxidectin in food animals

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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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