The Pharmaceutical Regulatory Process

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by to...

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Kaydedildi:
Detaylı Bibliyografya
Yazar: Berry, Ira R.
Diğer Yazarlar: Martin, Robert P.
Materyal Türü: Kitap
Dil:İngilizce
Baskı/Yayın Bilgisi: New York Informa Healthcare USA Inc. 2021
Edisyon:2nd ed.
Seri Bilgileri:Drugs and The Pharmaceutical Sciences Series Vol. 185
Konular:
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Diğer Bilgiler
Özet:This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.
Fiziksel Özellikler:x, 469 p.
ISBN:9780367202842