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Some agents have proven teratogenic potential. These agents are summarized. Although the effects of such agents are potentially variable and predictable, their use should be very limited or avoided during pregnancy.

Category D agents have proven teratogenic potential but may, under certain circumstances, be indicated. Prior to using any category D agent, providers should perform a careful review of indications, duration of therapy, all potential.effects, and all potential alternatives to the proposed therapy.

In addition,patients should be informed of these considerations, allowing for informed con-
sent to the proposed therapy. Category X medications have proven teratogenic potential and use should be avoided in pregnancy


Proven Human Teratogens


Category D

Cyclophosphamide
Lithium
Paramethadione
Phenytoin
Barbiturates
Benzodiazepines
Systemic retinoids
Tetracycline
Trimethodione
Valproic acid
Warfarin

Category X

Thalidomide
Danazol
Misoprostil
Diethylstilbesterol
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Refer pdf

Economic questions vise notes

Refer pdf and pharm d guru also

ICH GCP CDSCO

ICH GCP CDSCO guidelines

Various phases of CT

Various phases of CT in detail

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