New Drug Approval Process Book

Pt. I	Regulatory practices and procedures of new drug, biologic, and device development
1	Drug development teams	1
2	Nonclinical drug development : pharmacology, drug metabolism, and toxicology	19
3	The investigational new drug application and the investigator's brochure	63
4	General considerations of the new drug application	101
5	The new drug application, content and format	113
6	Abbreviated and supplemental new drug applications	173
7	The biologies license application (BLA)	185
8	Device legislation and application	213
9	Orphan drugs	239
Pt. II	Clinical research development
10	Clinical research protocols	257
11	Adverse experiences, adverse reactions, and interactions of drugs	287
12	Biostatistics in pharmaceutical product development - facts, recommendations, and solutions	313
13	Industry and FDA liaison	335
Pt. III	Specific aspects in the process of new product submissions
14	Chemistry, manufacturing, and control requirements of the NDA and ANDA	361
15	Data presentation for FDA submissions : text and tabular exposition	403
16	Preparing for FDA inspections : manufacturing sites	411
17	Technology change : advantages in the pharmaceutical industries	425
18	The common technical document for the registration of pharmaceuticals for human use	441
Pt. IV	Global applications of good clinical practices (GCPs)
19	Obligations of the investigator, sponsor, and monitor	481
20	Institutional review board independent ethics committee and informed consent : protecting subjects throughout the clinical research process	491
21	Quality assurance	511
22	Managing clinical trials	523
23	The European Union directive on good clinical practice in clinical trials : implications for future research	541
24	HIPAA : a new requirement to the clinical study process	559
Pt. V	Effective and new methodologies in expediting new product approvals in the U.S. and European Union
25	Working with a CRO	571
26	The evolving SMO in the United States	589
27	Accelerating new product approvals	601