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Chemistry / Pharmacology / Monobactam / Penicillin drug reaction / Aztreonam / Cephalosporin / Penicillin / Ampicillin / Amoxicillin / Enantiopure drugs / Beta-lactam antibiotics / Organic chemistry


Guidance for Industry Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing CrossContamination
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City

Washington D.C. / /

Company

Bernstein / ASM Press / /

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IndustryTerm

lactam-based products / manufacturing facility / finished pharmaceuticals / manufacturing controls / chemical manufacturing processes / unintended by-products / beta-lactam products / manufacturing practices / active pharmaceutical ingredients / manufacturing practice / manufacturing processes / food / manufacturing process / pharmaceuticals / air handling systems / basic chemical structure / control systems / manufacturing / manufacturing operations / air handling equipment / drug products / /

MedicalCondition

anaphylactic shock / serious allergic reactions / hives / reported penicillin allergy / anaphylaxis / immediate hypersensitivity / Drug Allergy / Clin Exp Allergy / hay fever / anaphylactic reactions / hypersensitivity / asthma / severe allergic reactions / IgE-mediated hypersensitivity / penicillin allergy / Middleton’s Allergy / drug-induced hypersensitivity / allergy / allergic reactions / /

MedicalTreatment

antibiotics / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / office of Compliance / office of Manufacturing and Product Quality / Food and Drug Administration Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / office of Communications Division of Drug Information / /

Person

Prescott / Jr. / Paz Arranz / Ann Intern Med / Ann Allergy Asthma Immunol / Vet Microbiol / /

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Product

cephalexin / Penicillin / ampicillin / cefaclor / ceftazidime / amoxicillin / /

ProvinceOrState

Maryland / /

Technology

antibodies / API / pharmacokinetics / /

URL

http /

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