YM Biosciences Inc. YM BioSciences is a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development. YM has proven regulatory and clinical...
AeroLEF
eroLEF® is a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe...
Catalent Pharma Solutions, Inc. Catalent offers a full range of product development services such as pre-clinical support, API development, analytical services, drug delivery development, clinical manufacturing, packaging, and regulatory consulting...
Inhaled
Our global pulmonary and nasal team, based in both the US and Europe, has extensive experience with the following inhaled delivery forms: Metered dose...
Forest Pharmaceuticals, Inc. Forest has well-established franchises in the therapeutic areas of the central nervous and cardiovascular systems, and we are always exploring new product opportunities that address a range of health conditions. Our...
Nycomed Nycomed is a privately owned, global pharmaceutical company with headquarters in Zurich, Switzerland. The company employs 12,000 associates worldwide and has affiliates in more than 50 countries.
Nycomed has a strong...
Alvesco
Alvesco® (ciclesonide), developed and marketed in collaboration with Sepracor, is an inhaled corticosteroid for the treatment of asthma. This prescription...
Irvine Pharmaceutical Services Irvine Pharmaceutical Services is a market leader providing accurate and reliable chemical and microbiological results to the Pharmaceutical, Biotechnology and Medical Device industries in a timely and dependable manner....
DRUG DELIVERY TECHNOLOGIES
Irvine is known as a dependable resource throughout the pharmaceutical and medical device industry for its experience in inhalation/nasal product...
Magellan Laboratories Incorporated Magellan Laboratories Incorporated was founded in 1991 by two leading pharmaceutical scientists: Alfred G. Childers, Ph.D. and W. Lowry Caudill, Ph.D. Their success in building Magellan Laboratories as a full-service...
Inhalation Product Development
Magellan Inhalation is dedicated to helping you develop and test your inhalation products. From dosage form selection and technology assessment to...
Pace Analytical Life Sciences, LLC Method development & validation, stability testing and storage, raw material testing, compendial testing, release testing, drug/device combination product testing, microbiology testing, extractables/leachables testing,...
The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices and components utilized in the manufacturing of the product. Packaging includes components such as vials, caps and stoppers. Drug delivery devices include nebulizers, syringes, medical devices and various types of inhalers. ...
To show that Minncare is effective against other microorganisms, the following in vitro tests were performed using a .5% solution of Minncare. All tests were done on aqueous test solutions at 20°C.
Concern regarding extractables and leachables has been increasing over the past few years, as evidenced by regulatory guidance documents [1-3]. One means of qualifying a component as being suitable for use in a drug product is to determine the extraction profile of that component in multiple solvents with polarities similar to and bracketing that of the product vehicle. Any observed extractables ...
An Overview of Setting Occupational Exposure Limits (OELs) for Pharmaceuticals Robert H. Ku, Ph.D., CIH, Principal Toxicologist [Published in Chemical Health & Safety, January/February 2000]
Setting appropriate occupational exposure limits is an integral component in assuring the health and safety of workers
Introduction Occupational exposure limits (OELs) 1 for the protection of workers have ...
In the manufacture of potent active pharmaceutical ingredients (APIs) and products, there is a need to conduct qualitative and/or quantitative healthbased risk assessments for both occupational and product (patient) safety purposes. When performed from an occupational standpoint, qualitative health-based risk assessments involve the categorization (“banding”) of the API based on toxicity and ...
The approval by the Food and Drug Administration (FDA) of the first inhaled insulin combination product for treatment of diabetes represents a milestone in drug delivery. Exubera is an inhaled powder form of recombinant human insulin (rDNA) used in the treatment of adult patients with type 1 and type 2 diabetes and is the first new delivery option introduced since the discovery of insulin in the ...
A Database coupled to a Statistical Analysis program is an effective means for establishing a control space, determining process capability of components and correlating leachable levels to extractable levels. Model fit and correlation based on two years of data collection indicate that the two inputs in the model cannot fully model the system.
A database coupled to a statistical analysis program is an effective means for defining a control space, determining process capability of components, establishing specifica- tions for components and drug product and potentially correlating leachable levels to component extractable levels.
Companies sponsoring clinical trials that rely on patient self-reported data for primary or secondary endpoints must be condent that such data is correct and trustworthy. Examples of self-reported data include symptom scores (e.g. peak expiratory ow, pain, nausea), patient experiences (e.g. medica- tion consumption, vomiting) and patient behavior (e.g. physical activity, sleep). Research using ...
Budesonide is an anti-inflammatory, synthetic corticosteroid used for the treatment of asthma by oral inhalation.The objective was to validate a sensitive and specific HPLC-MS/ MS assay to determine budesonide in human plasma for support of Sheffield Pharmaceutical clinical trials. An automated 96-well HPLC-MS/MS assay method for the determination of budesonide in human plasma was therefore ...
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