Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)
Sarfaraz K. Niazi
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete and timely description of every aspect of bioequivalence testing, including worldwide regulatory requirements for filing for approval of generic drugs, applying for a waiver, securing regulatory approval of reports, and obtaining regulatory certification of facilities conducting bioequivalence studies.
Kategori:
Tahun:
2007
Edisi:
1
Penerbit:
CRC Press
Bahasa:
english
Halaman:
550
ISBN 10:
0849383595
ISBN 13:
9780849383595
Fail:
PDF, 17.74 MB
IPFS:
,
english, 2007
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