Sale!

The Science and Regulations of Naturally Derived Complex Drugs

Original price was: د.إ955.00.Current price is: د.إ877.00.

Colour Matt Finished

Description

Pages:
329
Language:
English
Format:
PDF
Size:
8 MB
ISBN-10:
3030117502
ISBN-13:
978-3030117504

(AAPS Advances in the Pharmaceutical Sciences Series) 1st ed. 2019 Edition

by Ram Sasisekharan (Editor), Sau L. Lee (Editor), Amy Rosenberg (Editor), Larry A. Walker (Editor)

This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design.  The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear.  The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.

Reviews

There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.

53
    53
    Your Cart
    Audiology Diagnosis 2nd Edition
    1 X د.إ140.00 = د.إ140.00
    Handbook of Clinical Audiology 7th Ed
    2 X د.إ380.00 = د.إ760.00
    Basic Audiometry Learning Manual 3rd Edition
    1 X د.إ200.00 = د.إ200.00
    Girl in Pieces
    1 X د.إ33.00 = د.إ33.00
    Biochemistry and Its Application
    1 X د.إ100.00 = د.إ100.00
    Lecture Notes Clinical Biochemistry 9th Edition
    1 X د.إ200.00 = د.إ200.00
    Story Books for Kids
    1 X د.إ89.00 = د.إ89.00
    Encyclopedia of Herbal Medicine New Edition
    1 X د.إ166.00 = د.إ166.00
    Advances in Oral and Maxillofacial Surgery
    1 X د.إ15.00 = د.إ15.00
    The Behavioural Biology of Chickens By Siddaiah
    1 X د.إ6,700.00 = د.إ6,700.00
    1001 Interesting Facts About Everything
    1 X د.إ65.00 = د.إ65.00
    Biochemistry for Students 12th Edition
    1 X د.إ100.00 = د.إ100.00
    Antibiotic basics for clinicians
    1 X د.إ120.00 = د.إ120.00
    10 Minutes a Day Phonics for Ages 3-5
    2 X د.إ41.00 = د.إ82.00
    Alzheimers Disease By Alia Bucciarelli
    1 X د.إ100.00 = د.إ100.00
    General Science & Technology
    1 X د.إ29.00 = د.إ29.00
    Audiology Science to Practice 3rd Edition
    1 X د.إ250.00 = د.إ250.00
    Structured Reporting in Radiology
    1 X د.إ373.00 = د.إ373.00
    Micro and Nanotechnology for Neurotology
    1 X د.إ150.00 = د.إ150.00
    Allergies & asthma
    1 X د.إ55.00 = د.إ55.00
    WHO Classification of Skin Tumours 4th Edition
    1 X د.إ125.00 = د.إ125.00
    101 MRI Brain Solutions
    1 X د.إ15.00 = د.إ15.00
    Pediatric Nursing Care
    1 X د.إ566.00 = د.إ566.00
    Audiology Answers For Otolaryngologists
    1 X د.إ100.00 = د.إ100.00
    Snell's Clinical Anatomy by Regions
    1 X د.إ348.00 = د.إ348.00
    It's a Long Story: My Life
    1 X د.إ94.00 = د.إ94.00
    Animal Welfare 3rd Edition
    1 X د.إ200.00 = د.إ200.00
    Discoveries in Pharmacology
    1 X د.إ990.00 = د.إ990.00

    Add to cart