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Backward Thinking

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
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News and Press Releases

Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate

The Phase 3 ENSEMBLE study (NCT04505722) of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enrol and vaccinate study participants. ENSEMBLE is proceeding to enrol up to 60,000 participants worldwide.1
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White Papers

Changing Structural Landscape for Comparator Drug Supply

ADAllen Pharma

TransCelerate Biopharma is focused on advancing innovation in R&D, identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients. In 2013, they announced its Clinical Trial Comparator Network initiative to show a mutual commitment to offer secure and rapid supply of comparator drug products. The aim of this article is to unpack the section on 'Comparator Drugs' and analyse the rationale for attempting to achieve their objectives.
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Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
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