Menu
Sprawdź status swojego zamówienia
Skontaktuj się z nami
Książka Technology Transfer Ajay Babu Pazhayattil

Technology Transfer

Drug Product Manufacturing Process

Autor: Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram
Język: Angielski
Oprawa: Miękka
Wydawca: Springer, Berlin
Dostępność: Dostępna u dostawcy
Wysyłamy za 8-11 dni
415.36 zł
Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate...

Informacje o książce

Autor
Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram
Język
Angielski
Oprawa
Książka - Miękka
Data wydania
2024
strony
148
EAN
9783031322198
Enbook ID
46145268
Wydawca
Springer, Berlin
Waga
260
Wymiary
155 x 235

Pełny opis

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance.
This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirementsof the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook's authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.

Możesz być zainteresowany

Transatlantic Collapse of Urban Renewal

Christopher Klemek
454.69 zł

Something for Nothing?

David Hunt
114.96 zł

Advances in Control Techniques for Smart Grid Applications

Sajal Kumar Das
763.19 zł

International Review of Research in Developmental Disabilities

Robert M. Hodapp
984.64 zł

Journal of Dr. Elias Cornelius, a Revolutionary Surgeon

Elias Cornelius
37.27 zł

I Ching

JAMES LEGGE
140.72 zł

Educational Leaders in a Multicultural Society

Abul Pitre
392.82 zł

Hurry Up, Houdini!

Sal Murdocca
25.76 zł

Poesia y Algo Mas de Un Mexicano

Jose Antonio Yunes Salomon
55.04 zł

Water

Robin Clarke
254.52 zł

Shorebirds

Somers G. Headley
156.34 zł

Beyond Candlesticks - More Japanese Charting Techniques Revealed

Steve Nison
322.45 zł

Pattern Recognition and Machine Learning

Bishop
397.40 zł

New Penguin Dictionary of Civil Engineering

David Blockley
70.36 zł

Ecology of Invasions by Animals and Plants

C. S. Elton
212.95 zł

Paul Gauguin

Elizabeth Prelinger
275.41 zł

Klienci, którzy kupili tę książkę, kupili również

Geschichte von Mainz wahrend der ersten franzoesischen Occupation, 1792-1793

Karl Klein
146.97 zł

Annales Eduardi II Henrici De Blaneforde Chronica (1729)

Joannes De Trokelowe
161.61 zł

Analyse sismique d'un bâtiment asymétrique ? plusieurs étages

Vijay Kumar Shukla
161.61 zł

Weihnachten in Schweden

Elisabeth Grindmayer
113.98 zł