Spectroscopy Research | American Pharmaceutical Review - The Review of American Pharmaceutical Business & Technology

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Data Integrity: 2020 FDA Data Integrity Observations in Review
Tuesday, June 23, 2020
Michelle Neumeyer

In 2020 thus far, numerous warning letters have been issued from the FDA citing data integrity violations. Common findings violate principles of ALCOA... read more
The New Wave in Cancer Screening: Liquid Biopsy Testing
Sunday, April 30, 2017
Nigel Walker

Roche

The race for the liquid biopsy is on. The industry is still looking ahead to what will undoubtedly be the next big thing in oncology screening, the ... read more
The Data Generation
Wednesday, March 15, 2017
Cynthia A. Challener Ph.D.

Nice Insight

The pharmaceutical market landscape remains tremendously dynamic in 2017. Outsourcing practices for drug discovery, product and process development,... read more
Keys to Cultural Integration
Wednesday, March 15, 2017
Nigel Walker

That's Nice, Alcami Corporation

WHY IS CULTURAL INTEGRATION FOLLOWING A MERGER SO IMPORTANT TO THE SUCCESS OF THE NEWLY FORMED ENTITY? read more
An OEE Approach to Solid Dose Equipment Purchasing and Implementation
Wednesday, March 15, 2017
Adam Covitt

Federal Equipment

Acquiring pharmaceutical processing equipment and successfully integrating it into operations is not as straightforward as it may seem. Whether ... read more
Expanding the Commercial Options for Preparation of Amorphous Solid Dispersions
Wednesday, March 15, 2017
Márcio Temtem, Ph.D. João Vicente, Ph.D.

Hovione

Solubility in physiological fluids is a prerequisite for high bioavailability of drug substances. For many APIs that exhibit poor water solubility,... read more
Experience and Expertise Facilitate Controlled Substance Manufacturing
Wednesday, March 15, 2017
Patrick Hatem Kim Noll

Requirements for the manufacture of controlled substances impact all aspects of drug development, manufacturing and distribution. CDMOs that have ... read more
Investing for Successful Advancement of Viral Vector Manufacturing
Wednesday, March 15, 2017
Mark Bamforth, MBA Richard O. Snyder, Ph.D.

Brammer Bio

Gene therapies are designed to treat diseases by modifying genetic information, including correcting genes that function improperly or adding normal... read more
Enhancing Responsiveness with Embedded Flexibility
Wednesday, March 15, 2017
Gwenaël Servant, Ph.D.

Responsiveness has always been a key expectation for contract manufacturers providing services to the pharmaceutical industry. Today, however, with... read more
Industry Benchmark
Wednesday, March 15, 2017
Cynthia A. Challener Ph.D. Emilie Branch Steve Kuehn Carrie Cao, Ph.D., Dr. Andrew Warmington, Ph .D.

Nice Insight

At the heart of That’s Nice is the Nice Insight division, which provides data and analysis from proprietary annual surveys as well as custom ... read more
Changes In the Wind for the CDMO Market
Wednesday, March 15, 2017

Nice Insight

The global pharmaceutical market continues to grow at a healthy rate. According to research firm Evaluate Pharma, the global drug market will expand... read more
Achieving Security of Supply with Effective Particle Engineering
Wednesday, March 15, 2017
Arne Grumann

Fermion Oy

Targeted particle engineering for solid dosage drug formulations has become an imperative given the challenging compounds in the pharmaceutical ... read more
Spending on Contract Research Services Slowing Down
Wednesday, March 15, 2017

Nice Insight

The 2017 Nice Insight Clinical Research Organization (CRO) Outsourcing Survey1 includes input from 608 outsourcing-facing pharmaceutical and ... read more
Spending on Excipients Grows & Diversifies
Wednesday, March 15, 2017

Nice Insight

Pharmaceutical excipients are used in combination with APIs in multiple medicinal products, including tablets, capsules, oral liquids, transdermal ... read more
Growth Anticipated for Intermediates
Wednesday, March 15, 2017

Nice Insight

Pharmaceutical buyers have much lower budgets when it comes to buying intermediates than excipients or outsourced services, but their needs remain ... read more

Research Articles

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Data Integrity: 2020 FDA Data Integrity Observations in Review

The New Wave in Cancer Screening: Liquid Biopsy Testing

The Data Generation

Keys to Cultural Integration

An OEE Approach to Solid Dose Equipment Purchasing and Implementation

Expanding the Commercial Options for Preparation of Amorphous Solid Dispersions

Experience and Expertise Facilitate Controlled Substance Manufacturing

Investing for Successful Advancement of Viral Vector Manufacturing

Enhancing Responsiveness with Embedded Flexibility

Industry Benchmark

Changes In the Wind for the CDMO Market

Achieving Security of Supply with Effective Particle Engineering

Spending on Contract Research Services Slowing Down

Spending on Excipients Grows & Diversifies

Growth Anticipated for Intermediates

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