By Leon Shargel,Isadore Kanfer
In this period of elevated pharmaceutical festival, good fortune for widely used drug businesses depends on their skill to fabricate therapeutic-equivalent drug items in a cost-effective and well timed demeanour, whereas additionally being cognizant of patent infringement and different criminal and regulatory concerns.
Generic Drug Product improvement: sturdy Oral Dosage varieties, moment Edition offers in-depth discussions from greater than 30 famous experts describing the advance of common drug products—from the uncooked fabrics to the advance of a therapeutic-equivalent drug product to regulatory approval.
Major issues mentioned include:
- Active pharmaceutical ingredients
- Experimental formula improvement, together with a brand new part on caliber by way of layout (QbD)
- Scale-up
- Commercial product formulation
- Quality keep watch over and bioequivalence
- Drug product performance
- ANDA regulatory process
- Post-approval changes
- Post-marketing surveillance
- Legislative and patent demanding situations
This moment variation additionally features a new bankruptcy at the dating among the FDA and the us Pharmacopeia and in bankruptcy four, utilizing particular examples, the appliance of caliber via layout (QbD) in the course of formula improvement is examined.The booklet is a radical advisor to the advance of good oral commonly used dosage formulations. This textbook is perfect for the pharmaceutical undefined, graduate courses in pharmaceutical sciences, and healthiness execs operating within the zone of general drug development.
Read Online or Download Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition: Volume 3 (Drugs and the Pharmaceutical Sciences) PDF
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Additional info for Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition: Volume 3 (Drugs and the Pharmaceutical Sciences)
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Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition: Volume 3 (Drugs and the Pharmaceutical Sciences) by Leon Shargel,Isadore Kanfer
by John
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