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Guidance For Industry On Fixed Dose Combinations
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MODULE 7: TARGET PRODUCT PROFILES
www.who.intfixed-dose combinations Weight based dosing Possible to administer the same dosage form across multiple weight bands 1 formulation for children age <6 years; 1 formulation for age >6 years: adult (or half a dose) Possible to administer the same dosage form across multiple weight bands Administration considerations
DRAFT PHARMACEUTICAL DEVELOPMENT FOR …
www.who.intFixed-dose combinations (FDCs) are rare among prescription drugs. FDCs occur frequently in the WHO List of Essential Medicines and they have special features for pharmaceutical development. The manufacturing process development is the same for innovator and generic pharmaceutical industries. 1.1 Objectives