Electronic Resource

Active Pharmaceutical Ingredients Development, Manufacturing, and Regulation

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Pharmachemical manufacturing is that branch of fine chemical manufacturing that is directed to the manufacture of chemicals whose ultimate use will be in a final pharmaceutical dosage form, referred to as the active pharmaceutical ingredient (‘‘API’’). This industry segment has undergone very significant changes in much the same manner, but trailing, the pharmaceutical industry itself, from the time it emerged early in the 20th century. Thus, we must examine what has happened in the pharmaceutical industry over this period, in order to understand the implications for API manufacturing. This will lead us to the present time and to the goal of this book. It is our objective to provide a reference book that speaks to those issues that need to be addressed in order to assure that an existing or proposed pharmachemical operation will meet its objective of supplying an API to meet a medical=market need efficiently and effectively The changes are themselves a result of major changes that have occurred both directly and indirectly, in and on, the industry. These changes include company consolidations, both backward and forward integration, the increased and changed role of quality, the significant intensification of regulatory bodies worldwide, the impact of the greatly increased potency of APIs, thereby reducing pharmachemical requirements and the broadening of the market worldwide. These ideas will be discussed briefly here and touched on in depth in the subsequent chapters.

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Ketersediaan

EBK-00239

615.4/Sta-a

Perpus Pusat

Tersedia

Informasi Detail

Judul Seri

-

No. Panggil

615.4/Sta-a

Penerbit

United States of America : Taylor & Francis Inc.., 2005

Deskripsi Fisik

354 hlm

Bahasa

Indonesia

ISBN/ISSN

978-0-8247-0293-9

Klasifikasi

615.4

Tipe Isi

text

Tipe Media

e-book

Tipe Pembawa

-

Edisi

-

Subjek

Active Pharmaceutical
Ingredients
Manufacturing
Regulation
Development

Info Detail Spesifik

Electronic Version

Pernyataan Tanggungjawab

-

Versi lain/terkait

Lampiran Berkas

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