White Papers

Drug Labeling Specialist on New Pregnancy Labeling Rules

Pharmaceutical Development Group

On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the demise of pregnancy categories (A, B, C, D, X), which have been in use since 1979.

Drug Labeling Specialist on New Pregnancy Labeling Rules

Experienced Accessible Pharma Professionals and Global Regulatory Services

Pharmaceutical Development Group

PDG has experienced and accessible full-time professional staff and expert consultants including a multidisciplinary team of pharmacologists, toxicologists, clinicians, epidemiologists, statisticians, analytical scientists, regulatory professionals a...

Experienced Accessible Pharma Professionals and Global Regulatory Services

Critical Containment Products for the Pharmaceutical Industry

PBSC

Due to its relationship with US-based Presray, PBSC has been able to expand its product range for the laboratory and cleanroom settings and the two company's product ranges complement each other.

Critical Containment Products for the Pharmaceutical Industry

Pharmaceutical Consulting and Generic Drug Professionals

Pharmaceutical Development Group

On November 13, 2013, FDA proposed a new rule known as the 'Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products'.

Pharmaceutical Consulting and Generic Drug Professionals

Paediatric Clinical Trials 2016

SMI

Paediatric Clinical Trials 2016 - enhancing your paediatric strategy in line to maximise clinical benefits for patients.

Paediatric Clinical Trials 2016

Bioneer Biomarker Services

Bioneer

The attached white paper is a presentation from Bioneer, which provides more information about the company and the services it provides, including immune bioactivity human DCs, biomarkers and molecular histology.

Bioneer Biomarker Services

Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design

Pharmaceutical Development Group

Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design.

Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design

Medical Device Consultant on 510(k) Submissions

Pharmaceutical Development Group

As a medical device consultant, PDG® takes great interest in the ever-changing landscape of the premarket notification (510(k) review and clearance process.

Medical Device Consultant on 510(k) Submissions

Innovator or Generic, All Roads Lead to the 505(b)(2)

Pharmaceutical Development Group

Faced with decreasing R&D output, billions of dollars in patent expirations and increasing generic competition, innovators are forced to re-evaluate traditional business models.

Innovator or Generic, All Roads Lead to the 505(b)(2)

Kemwell: Keeping You Competitive

Kemwell

Kemwell is a 100% customer oriented company with expertise in contract development and manufacturing services for pharmaceutical and biopharmaceutical products.

Kemwell: Keeping You Competitive

Emerging Biotech Investment: Strategic Analysis of Private Equity and Venture Capital Funding

GlobalData

An excerpt from GlobalData's latest PharmaSphere report, this whitepaper provides in-depth analysis of the current trends and factors shaping the private equity (PE) and venture capital (VC) segments of the financial industry.

Emerging Biotech Investment: Strategic Analysis of Private Equity and Venture Capital Funding

Use of the Fios Genomics Analysis Approach for Determining Immunity Pathways

Fios Genomics

This study determined which immunological pathways are responsible for clearance of parasitic infections in people affected by river blindness.

Use of the Fios Genomics Analysis Approach for Determining Immunity Pathways

Rubber Oligomers Now Available at Toxikon

Toxikon Europe

Toxikon Europe, a leading lab in providing extractables and leachables services for the pharmaceutical industry, has developed a procedure to obtain and analyse pure rubber oligomers from rubber extracts.

Rubber Oligomers Now Available at Toxikon

Predicting TCA Toxicity Using In Vivo and Ex Vivo Juvenile Safety Models

IPS Therapeutique

The tri-cyclic antidepressant (TCA) amitriptyline is used in the treatment of nocturnal enuresis at doses of 2-7mg/kg in children, despite existing reports of severe cardiac toxicity at doses of 10mg/kg.

Predicting TCA Toxicity Using In Vivo and Ex Vivo Juvenile Safety Models

Bayesian Study Design: The Pragmatic Solution for Phase II Clinical Development

Quanticate

Bayesian Study Design: The Pragmatic Solution for Phase II Clinical Development

Bayesian Study Design: The Pragmatic Solution for Phase II Clinical Development

Tissues for Preclinical Drug and Biomarker and Safety Testing

Tissue Solutions

Tissues for Preclinical Drug and Biomarker and Safety Testing

Tissues for Preclinical Drug and Biomarker and Safety Testing

Management and Analysis of Biomarker Data

Exploristics

Management and Analysis of Biomarker Data

Management and Analysis of Biomarker Data

Pronexus Analytical - Neurochemical In Vivo Monitoring and Allied Bioanalytical Techniques

Pronexus Analytical

Pronexus Analytical - Neurochemical In Vivo Monitoring and Allied Bioanalytical Techniques

Pronexus Analytical - Neurochemical In Vivo Monitoring and Allied Bioanalytical Techniques

Peptide Synthesis, Polyclonal and Monoclonal Antibody Production

Storkbio Ltd

Peptide Synthesis, Polyclonal and Monoclonal Antibody Production

Peptide Synthesis, Polyclonal and Monoclonal Antibody Production

Acuros: Disposable Micropumps for Drug Delivery

Acuros GmbH

Acuros: Disposable Micropumps for Drug Delivery

Acuros: Disposable Micropumps for Drug Delivery

Effects of an Ultraviolet B Radiation Absorber on Photocarcinogenesis in Hairless Albino Mice

ETS Nederland

Effects of an Ultraviolet B Radiation Absorber on Photocarcinogenesis in Hairless Albino Mice

Effects of an Ultraviolet B Radiation Absorber on Photocarcinogenesis in Hairless Albino Mice