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The Camargo Blog

Get insight and information from our team of experts to improve your pharmaceutical development and commercialization strategy.

September 27th, 2017

Seamless Clinical Trials: Why Didn’t We Think of That?

April 19th, 2017

Special Protocol Assessment: Is It Important for Your Drug Development Program?

February 8th, 2017

Clinical Trials with Multiple Endpoints: Pitfalls and Management

February 1st, 2017

Real-World Evidence: Can It Really Be Used for Drug Approvals?

November 9th, 2016

Use of Clinical Data in a 505(b)(2) New Drug Application to Delay Nonclinical Testing

October 18th, 2016

Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and Drug Products

July 20th, 2016

Back to Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies—Pharmacokinetic Studies

May 31st, 2016

Back to Basics: 505(b)(2) FAQs Part 2: Clinical and Nonclinical Studies

September 26th, 2014

Alkermes Prodrug for Treatment of Multiple Sclerosis: NCE?

July 22nd, 2014

MannKind Breathes Easier—Inhaled Insulin Finally Approved

April 8th, 2014

The Road to Commercial Success—The Target Product Profile

May 28th, 2013

505(b)(2) Prodrug Fails Phase III Study

April 15th, 2012

Drug Development Planned Like the Titanic

June 14th, 2011

K-V’s Makena Part 4: Statistical versus Clinical Significance

June 8th, 2011

Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products

May 31st, 2011

K-V’s Makena: Part 3: Use of Public Information for 505(b)(2) Approvals

May 23rd, 2011

K-V’s Makena Part 2: Accelerated Approval Subpart H

March 23rd, 2011

Revised Safety Reporting for BE/BA Studies Effective March 28, 2011

December 13th, 2010

Use of Pharmacokinetic n(PK) Modeling & Steady-State Simulations in 505(b)(2) Drug Development

December 11th, 2010

Nuedexta®—Smart Pharmacology to Treat a Unique Disorder

October 6th, 2010

505(b)(2)s with Minimal Sponsor Studies

August 31st, 2010

Failed 505(b)(2)?: Vivus™ Qnexa

August 4th, 2010

New User Fees for 2011

May 19th, 2010

Prodrug Denied

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Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

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