Frequently Asked Question
Chapter 15Adverse Events with New Chemical Entities, Generics, Excipients, Placebos, and Counterfeits
Introduction
Generics
Excipients
Placebo
Other Manufacturers’ Drugs’ AEs
Placebo and Breaking the Blind in Clinical Trials
Picking up AEs Due to Excipients
Generics
Adverse Events with Counterfeit, Impure, and Other Non-standard Products
Online Pharmacies
Authors’ Comments for PV Personnel
Frequently Asked Questions
Chapter 16Children, Elderly, and Other Special (Vulnerable) Groups
Theory
Children
In the United States
In the European Union
The Elderly
FDA and the ICH E7 Guideline
FDA Guidance and Geriatric Rule
EMA
Other Special Groups
Women
African Americans
Chapter 17Pregnancy and Lactation
Introduction
Situation in the United States
Pregnancy
Lactation
Females and Males of Reproductive Potential
FDA Guidance on Pregnancy Registries — 2002
Good Epidemiologic Practices
Regulatory Reporting Requirements
Situation in the European Union
Lactation
AEs in Pregnant Partners of Males Taking a Drug
Other Resources
perinatology.com
Motherisk
Teratology Registries and Organizations
Frequently Asked Questions
Chapter 18Acute and Chronic (Late Occurring) Adverse Events, Adverse Events That Disappear (Bendectin) and Diethylstilbesterol
Introduction
Bendectin®: A False Alert
Market Removal
Return to the Market in Canada and Europe
Adriamycin®
Gene Therapy
Anti-retroviral Drugs
Diethylstilbestrol (DES)
Delayed Onset of Malignancy (Long Latency)
Actions Taken
Future for Long-Latency AEs
Frequently Asked Question
Chapter 19Drug Interactions
Introduction
Cytochrome P450
Drug–Food, Drug–Alcohol, Drug–Disease and Other
