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Blog & Resources Camargo Blog Clinical Studies, Phases I-IV

The Camargo Blog

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

November 29th, 2009

Generic or 505(b)(2)?

November 4th, 2009

GTx Needs a 2nd Phase III Trial and More Safety Data

September 14th, 2009

A Treatment IND is NOT the Same as an IND

July 10th, 2009

AstraZeneca Ends Collaboration With MAP Pharmaceuticals

May 29th, 2009

MAP Pharmaceutials 505(b)(2) Dihydroergotamine Orally Inhaled Product Meets Phase 3 Goals

May 15th, 2009

505(b)(2) IV Acetaminophen

May 15th, 2009

Quick-release Bromocriptine Mesylate Approved

April 17th, 2009

505(b)(2) Program: BTG’s Paxclitaxel Gel for Oesophageal Cancer

March 19th, 2009

One vs. Two Batches for Single-Dose and Multiple-Dose Studies

February 2nd, 2009

Dexlansoprazole Approved for the Treatment of GERD

January 29th, 2009

Watson’s 505(b)(2) Overactive Bladder Gel Approved by FDA

December 3rd, 2008

505(b)(2) Combination Meets Phase 3 Goals

August 22nd, 2008

Modeling Using Dissolution Data

August 21st, 2008

PK Modeling, Not Just Any Pretty Face

June 7th, 2008

Indevus’ Stock Drops 70% on FDA’s Request for More Safety Data

April 23rd, 2008

505(b)(2) Patent & Marketing Exclusivity

February 7th, 2008

A Single Phase 3 Trial Needed for 505(b)(2) Approval of a Combination Drug

January 17th, 2008

505(b)(2) with Only Phase 1 Study

January 16th, 2008

505(b)(2)—Part 2: The Assessment: Timeline, Cash Flows

December 12th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Marketing Assessment

December 10th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Development Plan

December 10th, 2007

505(b)(2)—Part 2: The Assessment: Regulatory Strategy

December 7th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Pharmacology

December 1st, 2007

505(b)(2)—Part 2: The Assessment: Pharmacokinetic Review

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