Specification of drug substances and products development and validation of analytical methods

Specification of drug substances and products development and validation of analytical methods

Saved in:

Bibliographic Details
Other Authors:	Riley, Shelley R. Rabel, Riley, Christopher M., Rosanske, Thomas W.
Format:	Book
Published:	Amsterdam Elsevier 2014
Subjects:	Drugs > standards
Online Access:	Click Here to View Status and Holdings.
Tags:	Add Tag No Tags, Be the first to tag this record!

Similar Items

Generic drug product development solid oral dosage forms
Published: (2014)

Pediatric drug development concepts and applications
Published: (2009)

Good practice of clinical drug trials
by: Spriet, Alain
Published: (2005)

Pharmaceutical process validation
Published: (2003)

How to Validate a Pharmaceutical Process
by: Ostrove, Steven A.
Published: (2016)

Improving drug safety a joint responsibility
Published: (1991)

Validation of active pharmaceutical ingredients
Published: (2001)

Generic drug product development solid oral dosage forms
Published: (2005)

Statistics in drug research methodologies and recent developments
by: Chow, Shein-Chung 1955-
Published: (2002)

New drug development regulatory paradigms for clinical pharmacology and biopharmaceutics
Published: (2004)

Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer
by: Willig, Sidney
Published: (2001)

Drug safety a shared responsibility
Published: (1991)

Good manufacturing practices for pharmaceuticals
Published: (2007)

Design and analysis of bridging studies
Published: (2013)

Drug Safety Evaluation Methods and Protocols
Published: (2017)

Computer techniques in preclinical drug development
by: Jackson, Robert C
Published: (1996)

Outsourcing in clinical drug development
Published: (2002)

Early phase drug evaluation in man
Published: (1990)

Integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development
Published: (1993)

Good manufacturing practices for pharmaceuticals a plan for total quality control
by: Willig, Sidney H.
Published: (1992)

Guidebook for drug regulatory submissions
by: Weinberg, Sandy 1950-
Published: (2009)

Handbook of drug screening
Published: (2001)

Theory of drug development
by: Holmgren, Eric B. 1959-
Published: (2014)

Toxicokinetics and new drugs development
Published: (1989)

Data and safety monitoring committees in clinical trials
by: Herson, Jay
Published: (2009)

Statistical issues in drug research and development
Published: (1990)

Clinical drug trials and tribulations
Published: (1988)

Optimization in drug discovery in vitro methods
Published: (2004)

A COMPREHENSIVE GUIDE TO TOXICOLOGY IN NONCLINICAL DRUG DEVELOPMENT
Published: (2017)

Drug safety evaluation
by: Gad, Shayne C. 1848-
Published: (2002)

Clinical measurement in drug evaluation
Published: (1995)

Development and approval of combination products a regulatory perspective
Published: (2008)

Pharmacoepidemiology and Pharmacovigilance Synergistic Tools to Better Investigate Drug Safety
by: Nour, Sabrina, et al.
Published: (2019)

Issues and impacts of foreign pharmaceuticals
Published: (2011)

Halal pharmaceuticals - general guidelines
Published: (2012)

Safety pharmacology in pharmaceutical development and approval
by: Gad, Shayne C. 1948-
Published: (2004)

Targeted regulatory writing techniques clinical documents for drugs and biologics
Published: (2009)

Principles of good clinical practice
Published: (2010)

Good clinical practice standard operating procedures for clinical researches
Published: (1998)

Handbook of phase I/II clinical drug trials
Published: (1997)