Preclinical

22 Results

Internal Standard (IS) Variation Case Studies: Emerging from Three Common IS Challenges

Content provided by WuXi AppTec | 01-Nov-2023 | Application Note

The use of internal standards (IS) is essential for developing and applying liquid chromatography-tandem mass spectrometric (LC-MS/MS) quantitative bioanalytical...

ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation

Content provided by WuXi AppTec | 20-Oct-2023 | Application Note

Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders...

PBPK modeling that saves you time and money

Content provided by Lonza Small Molecules | 09-Oct-2023 | White Paper

Understanding pharmacokinetic behaviors ahead of later-stage development means making informed decisions earlier. This enhanced capability helps your drug...

In Vivo Evaluation of a Gastro-Resistant HPMC-Based “Next Generation Enteric” Capsule

Content provided by Lonza Capsules & Health Ingredients | 01-Sep-2023 | White Paper

Invivo: Many orally dosed APIs are bioavailable only when formulated as an enteric dosage form to protect them from the harsh environment of the stomach....

Small Molecule development – getting it right

Content provided by Lonza Small Molecules | 20-Jun-2023 | Insight Guide

Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...

CNS Drug Development―One Partner From Discovery to Market

Content provided by Altasciences | 02-May-2023 | White Paper

As a leading partner in central nervous system (CNS) drug development, Altasciences’ in-house preclinical, clinical, bioanalytical, and manufacturing teams...

How Sponsors Reduce Chaos in Decentralized Trials

Content provided by Florence Healthcare | 08-Mar-2023 | Insight Guide

89% of research sponsors currently use and expect to continue the use of decentralized technologies and methods, according to our state of the industry...

The Complexities of Ophthalmic Drug Development

Content provided by Altasciences | 04-Oct-2022 | White Paper

Ophthalmic drug development comes with a unique set of challenges that can be mitigated by working with an end-to-end solution provider with regulatory...

Implementing Patient Co-Creation in Clinical Trials

Content provided by THREAD | 14-Jun-2022 | Insight Guide

Patient co-creation in clinical research means a shift from thinking about the patient to thinking with the patient. This means that patients are giving...

Strategic Approach to Immunogenicity Assessment

Content provided by Altasciences | 17-May-2022 | White Paper

In this issue of The Altascientist we provide a detailed overview on the different goals and challenges that are presented by the validation of immunogenicity...

Clear Guidelines for IND/CTA

Content provided by Altasciences | 24-Feb-2022 | White Paper

There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful...

Planning Your Preclinical Assessment

Content provided by Altasciences | 17-Jan-2022 | White Paper

There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful...

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Content provided by Frontage Laboratories | 01-Dec-2019 | White Paper

Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed,...

How to Avoid Surprises in Small-Molecule Drug Development Programs

Content provided by Frontage Laboratories | 01-Oct-2019 | White Paper

Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent...

Validating The Simoa Technology

Content provided by Frontage Laboratories | 01-Oct-2019 | White Paper

Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used...

The Truth about Physician Referrals and Clinical Trials

Content provided by BBK Worldwide | 24-Jul-2019 | White Paper

Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their...

Survey Report: State of the global pharmaceutical contract services industry 2018

Content provided by William Reed | 11-Jul-2018 | Research Study

In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of...

Leveraging Best Practices in Primary Packaging

Content provided by Catalent | 05-Mar-2018 | White Paper

When planning a clinical trial, overlooking the importance of primary packaging can be a mistake. From stability concerns to labeling to patient compliance...

FOR SALE/LEASE CRO/MRO turn key Research Campus, labs, vivariums, OR, archives, offices

Content provided by Northstar Private Capital LLC | 09-Aug-2016 | Product Brochure

Chazy, New York is located only six miles from the Canadian Border in Upstate New York. It is only ten minutes North of Plattsburgh, one hour south of...

How technology fights the challenges of clinical trials

Content provided by World Courier | 12-Oct-2015 | Case Study

Two of the biggest challenges in today’s global clinical trials are patient recruitment and retention. These problems often spring from clinical trial...

How Molded Manifold Assemblies Prevent Leaks

Content provided by AdvantaPure® | 08-Jun-2015 | White Paper

Pharmaceutical fluid transfer involves many tubing-to-fitting connections, and unfortunately those connections can leak and result in contamination, production...

The whole blood assay: Detection of broad spectrum of pyrogens & examples of medical device testing

Merck KGaA, Darmstadt, Germany | Recorded the 09-Apr-2015 | Webinar

Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard...

Preclinical

22 Results

Internal Standard (IS) Variation Case Studies: Emerging from Three Common IS Challenges

ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation

PBPK modeling that saves you time and money

In Vivo Evaluation of a Gastro-Resistant HPMC-Based “Next Generation Enteric” Capsule

Small Molecule development – getting it right

CNS Drug Development―One Partner From Discovery to Market

How Sponsors Reduce Chaos in Decentralized Trials

The Complexities of Ophthalmic Drug Development

Implementing Patient Co-Creation in Clinical Trials

Strategic Approach to Immunogenicity Assessment

Clear Guidelines for IND/CTA

Planning Your Preclinical Assessment

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

How to Avoid Surprises in Small-Molecule Drug Development Programs

Validating The Simoa Technology

The Truth about Physician Referrals and Clinical Trials

Survey Report: State of the global pharmaceutical contract services industry 2018

Leveraging Best Practices in Primary Packaging

FOR SALE/LEASE CRO/MRO turn key Research Campus, labs, vivariums, OR, archives, offices

How technology fights the challenges of clinical trials

How Molded Manifold Assemblies Prevent Leaks

The whole blood assay: Detection of broad spectrum of pyrogens & examples of medical device testing

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