Regulations

35 Results

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

FDA Focus̶ Product Design and Post Approval Changes

FDA Focus̶ Product Design and Post Approval Changes

Colorcon Inc. | 19-Sep-2016 | Technical / White Paper

Review a new Colorcon Technical Paper offering a summary of key points presented in the recent US Center for Drug Evaluation and Research (CDER) Guidance...

SGS-LSS

Amino Acid Analysis of Pharmaceutical Products

SGS Life Science Services | 11-Jul-2016 | Technical / White Paper

Amino Acid Analysis in general can be used for identification testing of biopharmaceutical active ingredients and the determination of impurities and related...

Article on Viral Clearance for Biopharmaceuticals

Article on Viral Clearance for Biopharmaceuticals

Catalent Pharma Solutions | 24-Aug-2015 | Technical / White Paper

Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals.  These studies are a key component...

I Holland: Sharing our knowledge and experience

I Holland: Sharing our knowledge and experience

I Holland Limited - Tabletting Science | 01-Feb-2015 | Event Programme

Maintenance training, seminars, our 7 Step Audit SOP and live webinars are a just few of the training opportunities I Holland have to offer. Click to find...

Meaningful Metrics – A CMO Perspective

Meaningful Metrics – A CMO Perspective

Patheon Inc | 19-Jan-2015 | Technical / White Paper

Learn about the roles of sponsors and their contract manufacturing organization (CMO) partners regarding metrics, what metrics to measure, how to manage...

USP<233> Elemental Impurities Sample Prep Strategy

USP<233> Elemental Impurities Sample Prep Strategy

SGS Life Science Services | 03-Nov-2014 | Technical / White Paper

Although USP <232> and <233> are still under discussion, a good deal of work is going on ahead of implementation in terms of method development....

Want to Strengthen Your Supply Chain Security?

Want to Strengthen Your Supply Chain Security?

Information not available | 18-Mar-2014 | Event Programme

The challenges of ensuring safe drugs for patients are universal, international and pervasive. The Global Forum on Access to Safe Medicines brings together...

SGS Group Management

Method Validation for Heavy Metals Testing

SGS Life Science Services | 04-Mar-2014 | Technical / White Paper

USP proposed <232> and <233> changes require ICP and ICP-MS instrumentation and methodology expertise, and knowledge of sample preparation....

Film Coating for Pediatric Oral Solid Dosage Forms

Film Coating for Pediatric Oral Solid Dosage Forms

Colorcon Inc. | 14-Jan-2014 | Technical / White Paper

With careful selection, of an appropriate film coating system, pediatric products may be coated with a suitable color while also providing mechanical integrity,...

Mitigating Medication Errors with Tablet Design

Mitigating Medication Errors with Tablet Design

Colorcon Inc. | 09-Dec-2013 | Technical / White Paper

Medical prescription drug errors by doctors, pharmacists and patients account for 1.5 million incidences of sickness, injuries or deaths in the U.S. each...

NEOBEE® MCTs Enhance Pharmaceutical Bioavailability

NEOBEE® MCTs Enhance Pharmaceutical Bioavailability

Stepan Lipid Nutrition | 04-Nov-2013 | Technical / White Paper

An efficient solvent for many lipophylic drugs and vitamins, NEOBEE® MCTs emulsify in aqueous environments and help uptake in intestinal cells. They are...

Pharmaceutical Material Identification

Pharmaceutical Material Identification

Thermo Fisher Scientific | 18-Sep-2013

Thermo Scientific TruScan RM and microPHAZIR RX analyzers are revolutionary instruments that can help you achieve compliance and realize a rapid return...

Id Counterfeit Pharmaceuticals with Portable Raman

Id Counterfeit Pharmaceuticals with Portable Raman

Rigaku Raman Technologies | 22-May-2013 | Technical / White Paper

The growing danger of counterfeit and substandard medicines entering the supply chain is a concern for global pharmaceutical manufacturers and consumers....

 Increasing Accuracy, Not Costs

Increasing Accuracy, Not Costs

METTLER TOLEDO | 11-Apr-2013 | Case Study

Pharmaceutical manufacturers worldwide are turning to vision inspection as a way to safeguard their brands, keeping products with label and packaging defects...

White Paper: Is My Method Still Valid?

White Paper: Is My Method Still Valid?

SGS Life Science Services | 26-Mar-2013 | Technical / White Paper

The goal of method validation is to pro­vide proof that data from each individual sample is indicative of the actual batch content with little deviation....

Extractables & Leachables Risk Assessment

Extractables & Leachables Risk Assessment

SGS Life Science Services | 04-Feb-2013 | Technical / White Paper

An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European...

Partnering with Your CDMO for CMC Preparation

Partnering with Your CDMO for CMC Preparation

DPT Laboratories | 26-Sep-2012 | Insight Guide

Collaborative partnering between Contract Development and Manufacturing Organizations (CDMO) and the drug product submission applicants is becoming increasingly...

Radio Ion Chromatography

Radio Ion Chromatography

Metrohm – customized analysis for the pharmaceutical industry | 17-Sep-2012 | Data Sheet

Radio Ion ChromatographyPositron emission tomography (PET) is one of the most powerful noninvasive diagnostic tools for tracing organ functioning. Quality...

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